DMCG Careers

Want to join our team? Attach your resume, and we will contact you as soon as a position is available. DMCG is constantly working on new client needs. Here are some of the general client role descriptions that DMCG is currently looking to fill. If you are interested please send your MS Word (no PDF) format resume. One of our representatives will contact you as soon as possible.

Resumes to: careers@dmcginc.com

Specialist Quality Complaints – (29665)
Juncos, PR

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Doctorate degree in Sciences or Master’s degree & 3 years of investigation experience or Bachelor’s degree in Sciences & 5 years of investigation experience.

The Specialist conducts facilitates cross-functional teams to conduct complex complaint investigations, determines corrective actions with their effectiveness and determines the steps necessary to ensure the proper level of control for product in distribution. Aligns complaint closure requirements in adherence with pre-determined process step metrics to ensure timely closure of records.

Key Responsibilities:
• Ensures quality of complaint records
• Facilitate cross-functional meetings to plan and coordinate the plan for closure of records
• Applies analytical skills and product knowledge to evaluate complex situations using multiple sources of information
• Executes against prioritized work plans
• Quickly escalates issues that could impede the ability to close records according to action plans
• Maintains compliance with local and global processes
• Execution of regulatory and SOP requirements
• Anticipates and prevents potential issues with regulators
• Provides guidance and technical advice
• Evaluates subject matter expert assessments
• Escalates potential Quality issues to Management

Primary responsibilities include: Supporting the product complaint system at Client through; leading and managing product complaint investigations, performing data analysis and trending of complaint information to proactively detect signals and take appropriate actions in a timely manner. Functions: Keep the complaints database updated as soon as factual information is available and summarize closed investigations into the database accurately. Ensure complaint related investigations are concise, clear and science-based by reviewing and approving such investigations.
Follow-up on corrective actions derived from investigations through completion. On occasion, depending on the nature and complexity of the complaint, the specialist may be responsible of conducting and documenting the investigation. Therefore, the candidate must possess excellent writing skills that include closing the gap between a highly technical investigation into a simple and concise document that can be understood by non-technical reviewers.
May also include: Communication and escalation of complaints, site representation on the product complaint network and generation and issuance of closure letters to patients and business partners.

Education/Licenses: Doctorate degree or Master’s degree & 3 years of experience directly related to the job or Bachelor’s degree & 5 years of experience directly related to the job

COMPETENCIES/SKILLS:
Strong project management skills, experience leading cross-functional teams, and the ability to handle multiple projects simultaneously is a must.
Excellent written and verbal communication skills, including facilitation and presentation skills.
Able to work in a team-oriented, matrix environment and work effectively with diverse departmental groups
Be self-motivated, able to interface effectively with various levels, attentive to details and able to prioritize and meet deadlines, and must possess excellent leadership, problem solving, analytical, influencing and customer service skills to operate and deliver results in a matrix-managed GMP environment.
Computer literacy, independently understand, follow and implement instructions, work independently or as a team player and collaborate with outside resources, and the ability to evaluate issues, make decisions and determine when to escalate, as necessary.

Process Development Sr. Scientist – (29678)
Juncos, PR

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Doctorate degree in Sciences/Engineering or Master’s degree in Sciences/Engineering and 3 years of directly related experience or Bachelor’s degree in Science/Engineering and 5 years of directly related experience

Process and Equipment characterization and validation.

To independently conceive, design, implement and advance scientific experiments, which contribute to the successful completion of goals and/or projects. Interprets experimental strategies or leads these activities.
Provides input to new processes to generate robust and reliable data. Functions as a lead scientific / technical resource or as a project leader.
Functions:
Independently monitors or conducts experiments, studies, or a series of experiments/studies to advance projects or technologies
Provides advanced data analysis and interpretation, and assesses impact of data on the project and makes recommendations
Expands knowledge-seeking beyond core area of expertise
Identifies relevant external competitive knowledge
Independently prepares new and novel protocols/experimental design
Key contributor to an independent research/project team
Initiates productive collaborations outside of the department or company
Introduces new or advanced technologies and/or concepts
May contribute to scientific journal articles or complex technical documents as lead author
Leads department-wide support efforts such as safety, recruiting and committees
Develops supervisory and mentoring skills
Makes proactive decisions that contribute to the achievement of milestones
Plans detailed procedures for defined projects, including timelines, milestones, methodological approaches, expected results and necessary resources
Education/Licenses: Doctorate degree and 2 years of directly related experience or Master’s degree and 6 years of directly related experience.

COMPETENCIES/SKILLS
Ability to motivate, lead and/or supervise the activities of others.
Ability to develop realistic timelines.
Be able to problem solve using the application of scientific theory.
Demonstrate skills in independently determining and developing scientific analysis and solutions.
Exercise considerable latitude in determining objectives of scientific work.
Demonstrate strong laboratory and project management skills.
Creative skills in the development of new hypotheses for scientific experiments.
Critical evaluation and detailed interpretation of results.
Demonstrate knowledge of scientific relevance of targeted work.
Bilingual (English and Spanish preferred).

Sr. Validation Scientist – (29679)
Juncos, PR

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Sr Validation Scientist – 29679 – Juncos, PR Non Standard Shift
Doctorate degree in Science/Engineering or Master’s degree in Sciences/Engineering and 3 years of directly related experience or Bachelor’s degree in Sciences/Engineering and 5 years of directly related experience
Process and Equipment characterization and validation.

Independently provides and/or directs the technical validation engineering support of process and/or equipment upgrades, replacements, and modifications in the laboratory, manufacturing or manufacturing support environment. Able to troubleshoot systemic validation issues. Applies advanced and diverse validation engineering principles to the design and implementation of major system or process modifications and/or capital projects. Develops, organizes, analyzes and presents interpretation of results for operational issues or validation engineering projects of significant scope and complexity. Complete complex or novel assignments requiring development of new and/or improved validation engineering techniques and procedures. Develop validation engineering policies and procedures that affect multiple organizational units. Supervise, coordinate and review work of a small staff of engineers and/or technicians on an ongoing basis as well as on a project basis. Employ advanced validation engineering techniques and/or modifications of advanced techniques within area of validation engineering expertise. Apply knowledge of validation engineering principles and practices outside of area of expertise to broad variety of assignments in related fields. Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity. Work with manufacturing, process development, utilities, facilities, labs, and/or quality assurance in developing requirements and recommendations for large and/or highly complex process, system/facility modifications. Work with project managers to complete the validation responsibilities of engineering projects within schedule, budget and quality constraints. Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project. Prompt and regular attendance to the workplace.

*Other functions may be assigned

Knowledge:
Advanced validation knowledge (equipment qualification, cleaning, sterilization).
Applies extensive technical validation expertise, and has full knowledge of other related disciplines.
Problem Solving:
Provide technical solutions to a wide range of difficult problems. Solutions are imaginative, thorough, practicable, and consistent with organization objectives.
Discretion/Latitude:
Exercises considerable latitude in determining technical objectives of assignment. Completed work is reviewed from a relatively long- term perspective, for desired results.
Supervision and guidance relate largely to overall objectives, critical issues, new concepts, and policy matters.
Impact:
Essential to the completion of broad programs and projects.
Decisions, recommendations and actions form the basis of site/local program schedules and personnel/fiscal resource utilization.
Leadership:
Leads efforts of group of peers directly supervises staff or project resources.
Guides the successful completion of major programs and may function in a project leadership role.
May be expected to directly supervise staff or project resources.
Liaison:
Represents the organization as the prime technical contact on contracts and projects. Interacts with senior external personnel on significant technical matters often requiring coordination between organizations.
Regulatory:
Understands regulatory trends in industry and able to make connection between those trends and established corporate direction. Some direct experience with FDA or equivalent regulatory body.
Represents the organization as the technical expert to endorse the organization’s validation programs and practices

EDUCATION/LICENSES

Doctorate degree or Master’s degree and 3 years of directly related experience or Bachelor’s degree and 5 years of directly related experience or Associate’s degree and 10 years of directly related experience.

COMPETENCIES/SKILLS

In-depth knowledge of validation processes and requirements
Interacts effectively with variety of communication and working styles
Ability to independently determine when additional internal resources are required to solve problems
Ability to handle multiple projects at one time
Demonstrated Skills in the following areas:
Schedule development
Facilitation
Collaboration
Basic project management
Completion and follow-up
Technical expertise areas of validation engineering.
Ability to independently determine when additional external resources are required to solve problems
Ability to provide solutions to a large variety of technical problems of moderate to large complexity and scope
Problem solving skills requiring the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach.
Working knowledge of financial analysis tools
Ability to delegate and manage the project work of others
Demonstrated Skills in the following areas:
Negotiation, persuasion and facilitation
Collaboration
Project cost development
Conflict Resolution
Decision Making
Leadership and teambuilding
Management of contractors and vendors

Specialist QA – (29682)
Juncos, PR

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Doctorate degree in Sciences or Master’s degree in Sciences and 3 years of Quality experience or Bachelor’s degree in Sciences and 5 years of Quality experience

Experience in Quality performing batch record audit, non-conformances, oversight, on-the-floor support of Manufacturing; additionally, experience applying continuous improvement and Lean principles to reduce lead times and improve Quality

Perform one or more of the following duties and responsibilities in support of Client’s Quality Assurance program under minimal supervision. Review and approve product MPs. Approve process validation protocols and reports for manufacturing processes. Request Quality on incident triage team. Approve Environmental Characterization reports. Release of sanitary utility systems. Approve planned incidents. Represent QA on NPI team. Lead investigations. Lead site audits. Own site quality program procedures. Designee for QA manager on local CCRB. Review Risk Assessments. Support Automation activities. Support facilities and environmental programs. Review and approve Work Orders. Review and approve EMS/BMS alarms. Approve NC investigations and CAPA records. Approve change controls. Provide lot disposition and authorize lots for shipment.
Doctorate degree or Master’s degree and 3 years of directly related experience or Bachelor’s degree and 5 years of directly related experience or Associate’s degree and 10 years of directly related experience. COMPETENCIES/SKILLS Project management skills, Strong organizational skills, including ability to follow assignments through to completion, Initiate and lead cross functional teams, Enhanced skills in leading, influencing and negotiating, Strong knowledge in area of expertise, Collaborate and coordinate with higher level outside resources, Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development, Demonstrate ability to interact with regulatory agencies, Strong word processing, presentation, database and spreadsheet application skills, Strong communication (both written and oral), facilitation and presentation skills, Strong skill in working independently and to effectively interact with various levels, Advanced data trending and evaluation
Ability to evaluate compliance issues, Demonstrate the Client Values/Leadership Practices.

Sr. Project Manager – (29685)
Juncos, PR

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Doctorate degree and 2 years of Project Management experience OR Master’s degree and 4 years of Project Management experience OR Bachelor’s degree or and 6 years of directly Project Management. Preferably in Chemical or Industrial Engineer

• Skills in handling multiple responsibilities, priorities, tasks, and projects simultaneously.
• Skills in working under time pressure.
• Practical project management software and spreadsheet skills, proficient computer operation skills.
• Effective interactions in a team or matrixes environment
• Good organizational skills, detail-oriented & accurate, analytical skills.
• Must be a team player, self-starter, strategic thinker, persistent, tactful, and persuasive.
• Fluent business English and Spanish, written and oral
• Effective verbal and written communication skills (writing and presentations).
• Must be capable of growth and increased responsibility.
• Understanding and experience with Ariba Sourcing and Contracting Modules. Experience with SAP, Trackwise and Project management tools preferred.
• Highly proficient with MS Office, including Excel, Word, and PowerPoint
SUMMARY
Oversees, manages and coordinates all operational aspects of ongoing department level projects having significant impact on multiple organizations. Serves as liaison between project team and organization.

General role description

Oversees, manages, and coordinates all operational aspects of ongoing department level projects having significant impact on multiple organizations. Serves as liaison between project team and organization.

FUNCTIONS
1. Manage all aspects of project(s): planning, implementation, monitoring, completion, and follow-up.
2. Manage competing timelines and prioritize critical tasks. Establish and achieves project standards for work quality and quantity.
3. Assess project issues and develop solutions to meet scientific, productivity, quality and client satisfaction goals and objectives.
4. Assist in technical, financial, and organizational issues by researching issues, providing recommendations, and maintaining document archives.
5. Manage and track project budget(s).
6. Negotiate and reconcile the use of resources for the projects.
7. Identify and anticipate schedule slips or changes and analyzes the costs and resource impact.
8. Develop and implement tools, techniques, and processes to provide or create information to enable informed decision making within the teams.
9. Actively participate in directing the evolution and defining the role of the project
10. Ensure the project goals and objects are well understood by the various functional areas.
11. Liaison with Management, Department Heads, Leaders, sub or satellite team leaders and members to obtain
their continued input and feedback on the benefits, needs, and issues associated with the project.
12. Maintain the master project plan and schedule for assigned projects.
13. Recommend and develop operational or process improvements for the performance and successful functioning of the project team.
14. Provide senior management and department heads with project management support on an as needed basis as well as for special projects.
15. May manage and direct the activities of project support staff
16. Conduct annual performance reviews and provides career counseling and general guidance.
17. Identify or leads focus area projects within the overall function of project management or related projects.
18. Generate periodic updates and prepare formal presentations for required forums.
19. Generate individual and more complex reports utilizing various resources.
20. Ensure project work complies with domestic (may also involve international) regulatory requirements and approved guidelines relevant to area of responsibility.
21. Ensure project work complies with practices, policies, and standard operating procedures.
22. Participate in required meetings, activities, and related projects and relevant interdepartmental activities.
23. Anticipate resource needs and communicate to management sponsors.

** Other functions that may be assigned.

EDUCATION

Doctorate degree and 2 years of Project Management experience OR Master’s degree and 4 years of Project Management experience OR Bachelor’s degree or and 6 years of directly Project Management.

PREFERRED QUALIFICATIONS
• Skills in handling multiple responsibilities, priorities, tasks, and projects simultaneously.
• Skills in working under time pressure.
• Practical project management software and spreadsheet skills, proficient computer operation skills.
• Effective interactions in a team or matrixes environment
• Good organizational skills, detail-oriented & accurate, analytical skills.
• Team player, self-starter, strategic thinker, persistent, tactful, and persuasive.
• Effective verbal and written communication skills (writing and presentations).

Process Development Scientist – (29687)
Juncos, PR

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Doctorate degree in Engineering or Materials Science (Chemistry or Physics)
or
Master’s degree in Engineering or Materials Science (Chemistry or Physics) and 3 years direct related experience
or
Bachelor’s degree in Engineering or Materials Science (Chemistry or Physics) and 5 years of direct experience.

• Educational background in Engineering or Sciences (Chemistry or Physics)
• Knowledge in Material Sciences (glass/polymers)
• Familiarity with Biopharmaceutical Environment
• Knowledge in Primary Packaging (vials, syringes, cartridges, etc.)
• Knowledge in Glass Forensics
• Advanced scientific analysis and troubleshooting skills
• Able to work in a laboratory environment
• Advanced laboratory work skills
• Experience using stereomicroscopes, calipers, X-Ray/CT Scan Equipment, etc.
• Ability to motivate and/or supervise the activities of others
• Must be well organized, have multi-task project experience, and be able to communicate and work well with other departments
• Ability to interpret and apply GMPs
• Adheres to company policies and procedures to ensure a continuous state of compliance
• Familiarity with documentation in a highly regulated environment
• Ability to handle multiple tasks/priorities simultaneously at one time
• Able to interact effectively with variety of communications and working styles
• Must have demonstrated skills and competencies in the following areas:
o Verbal communication in English and Spanish
o Written communication in English and Spanish including technical writing skills, negotiation and conflict resolution
o Analytical problem-solving
o Project management

To conceive, design, implement and execute specific scientific experiments, which contribute to the successful completion of goals and/or projects under general guidance of supervisor. Under general guidance of supervisor,
Conceives and designs, executes or evaluates, and interprets experimental strategies. Provides input to new processes to generate robust and reliable data. Ensures that studies are conducted in compliance with the respective protocol and applicable guidelines and regulations. Designs, monitors or conducts experimental strategies with general guidance from supervisor. Provides data analysis and interpretation and assesses impact of the data on the project. Keeps current in field of scientific expertise and areas relevant to their function. Monitors field of expertise, including literature and technology development, and communicates relevant observations. May introduce advanced scientific methods. Develops and implements new and novel protocols to address specific issues. May represent the department on project teams under supervision of a senior scientific staff member. May initiate productive collaborations within and outside of the department or company. Advises or assists others in experimental design and/or interpretation/diagnosis of data and implementing innovative remedies. Independently authors scientific reports, summary documents, complex regulatory documents, invention disclosure submissions and/or patents. Participates in external scientific community. May assume lead role in department-wide support efforts such as safety, recruiting and committees. May develop supervisory and mentoring skills. Develops and follows timelines for completing project team work.
Doctorate degree or Master’s degree and 3 years of directly related experience or Bachelor’s degree and 5 years of directly related experience or Associate’s degree and 10 years of directly related experience.

COMPETENCIES/SKILLS Advanced scientific analysis and troubleshooting skills.
Advanced laboratory work skills. Ability to motivate and/or supervise the activities of others.
Must be well organized, have multi-task project experience, and be able to communicate and work well with other departments. Must have demonstrated skills and competencies in the following areas: Verbal communication
Written communication including technical writing skills, negotiation and conflict resolution Analytical problem-solving Project management Ability to be flexible and manage change. Computer literacy (Windows environment: Word, Excel, Power Point). Skills requiring the application of scientific theory. Creative skills in the design and performance of scientific experiments and interpretation of results. Strong knowledge of cGMP’s. Fully bilingual (English/Spanish).

Specialist QA – (29689)
Juncos, PR

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Must be available for nonstandard shift

Master’s degree in Sciences/Engineering and 3 years of Quality experience or Bachelor’s degree in Sciences/Engineering and 5 years of Quality experience

Experience in Quality Assurance, and / or Aseptic processing preferred. Good decision making skills, and self-starter.

Perform one or more of the following duties and responsibilities in support of Client’s Quality Assurance program under minimal supervision. Review and approve product MPs. Approve process validation protocols and reports for manufacturing processes. Request Quality on incident triage team. Approve Environmental Characterization reports. Release of sanitary utility systems. Approve planned incidents. Represent QA on NPI team. Lead investigations. Lead site audits. Own site quality program procedures. Designee for QA manager on local CCRB. Review Risk Assessments. Support Automation activities. Support facilities and environmental programs. Review and approve Work Orders. Review and approve EMS/BMS alarms. Approve NC investigations and CAPA records. Approve change controls. Provide lot disposition and authorize lots for shipment.
Doctorate degree or Master’s degree and 3 years of directly related experience or Bachelor’s degree and 5 years of directly related experience or Associate’s degree and 10 years of directly related experience. COMPETENCIES/SKILLS Project management skills, Strong organizational skills, including ability to follow assignments through to completion, Initiate and lead cross functional teams, Enhanced skills in leading, influencing and negotiating, Strong knowledge in area of expertise, Collaborate and coordinate with higher level outside resources, Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development, Demonstrate ability to interact with regulatory agencies, Strong word processing, presentation, database and spreadsheet application skills, Strong communication (both written and oral), facilitation and presentation skills, Strong skill in working independently and to effectively interact with various levels, Advanced data trending and evaluation
Ability to evaluate compliance issues, Demonstrate the Client Values/Leadership Practices.

Project Manager – (29692)
Juncos, PR

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Administrative Shift

• Doctorate degree in Life Sciences and/or Business Administration
Or
• Master’s degree in Life Sciences, Business Administration, Finance and/or Engineering and 3 years of experience in Business Planning, Manufacturing or Supply Chain Functional Operations
Or
• Bachelor’s degree in Life Sciences, Business Administration, Finance and/or Engineering and 5 years of experience in Business Planning, Manufacturing or Supply Chain Functional Operations
• Project Management experience
• Strong Problem Solving and Analytical Skills
• Fluent oral and written communication skills in English and Spanish

Preferred Qualifications
• Experienced with change control system and processes. Has led and owned change controls within a Quality GMP system
• Strong organizational skills, detail-oriented & accurate, analytical and technical writing skills
• Strong project management skills in handling multiple responsibilities, priorities, tasks, and projects simultaneously
• Fluent English and Spanish (verbal and written). Effective verbal and written communication skills
• Knowledge of supply chain planning, scheduling, master data and procurement processes
• Skills in working under time pressure, and effectively in a team matrix environment.
• Ability to influence staff and effect change outside of area of responsibility
• Good decision-making skills
• Possess an understanding and appreciation of the Client Values and Leadership Attributes
• Teamwork oriented, self-starter, persistent, tactful, and persuasive.
• Proven ability to deliver results
• GMP and GXP knowledge in Pharmaceutical industry
• Knowledge on improving processes and able to change in an ambiguous environment

*****************************************
1. Specific educational / software requirements
a. In addition to the listed, staff has to be fully bilingual as daily activities interact with Client network staff at other locations
b. This person will track projects in SmartSheet and Excel
c. This person will own and manage change controls using Trackwise

SUMMARY
Oversee, manage and coordinate all operational aspects of ongoing department projects impacting multiple departments. Serves as liaison between project team and department.

FUNCTIONS
1. Manage all aspects of project(s): planning, implementation, monitoring, completion, and follow-up.
2. Manage competing timelines and prioritize critical tasks. Establish and achieves project standards for work quality and quantity.
3. Assess project issues and develop solutions to meet scientific, productivity, quality and client satisfaction goals and objectives.
4. Assist in technical, financial, and organizational issues by researching issues, providing recommendations and maintaining document archives.
5. Maintain and track project budget(s).
6. Reconcile the use of resources for the projects.
7. Identify and anticipate schedule slips or changes and analyzes the costs and resource impact.
8. Implement tools, techniques and processes to provide or create information to enable informed decision making within the teams.
9. Actively participate in directing the evolution and defining the role of the project
10. Ensure the project goals and objects are well understood by the various functional areas.
11. Liaison with department staff, sub or satellite team leaders and members to obtain their continued input and feedback on the benefits, needs, and issues associated with the project.
12. Maintain the master project plan and schedule for assigned projects.
13. Recommend and develop operational or process improvements for the performance and successful functioning of the project team.
14. Provide department management with project management support on an as needed basis as well as for special projects.
15. May manage and direct the activities of project support staff
16. Conduct annual performance reviews, and provides career counseling and general guidance.
17. Identify or lead focus area projects within the overall function of project management or related projects.
18. Generate periodic updates and prepare formal presentations for required forums.
19. Generate individual and more complex reports utilizing various resources.
20. Ensure project work complies with domestic (may also involve international) regulatory requirements and approved guidelines relevant to area of responsibility.
21. Ensure project work complies with practices, policies and standard operating procedures.
22. Participate in required meetings, activities, and related projects and relevant interdepartmental activities.
23. Anticipate resource needs and communicate to management sponsors.

• Other functions that may be assigned.

EDUCATION
Doctorate degree OR Master’s degree and 2 years of Project Management experience OR Bachelor’s degree and 4 years of Project Management experience.

PREFERRED QUALIFICATIONS
• Skills in handling multiple responsibilities, priorities, tasks, and projects simultaneously.
• Skills in working under time pressure, and effectively in a team matrix environment.
• Practical project management software and spreadsheet skills, proficient computer operation skills.
• Effective interactions in a team or matrixes environment.
• Good organizational skills, detail-oriented & accurate, analytical skills.
• Team player, self-starter, persistent, tactful, and persuasive.
• Effective verbal and written communication skills (writing and presentations).
• Ability to assume increasing levels of responsibility.

Specialist Quality Control – (29639)
Juncos, PR

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Administrative Shift – Remote during COVID 19 situation

Master’s degree in Sciences & 3 years of Quality experience or Bachelor’s degree in Sciences & 5 years of Quality experience.

• Experience in the creation of systems visualizations using tools such as Spotfire / Tableau
• Direct experience in the support and maintenance of laboratory electronic systems (LIMS / CIMS / LMES)
• Template Creation & Maintenance
• Skilled on data analysis by developing reports using SQL like tools (SQL / Brio / Cognos)
• Customer service oriented by able to support our clients on technical needs related to QC electronic systems

Description:
Under general direction, functions as the technical specialist for testing & development in areas of molecular biology and microbiology. Focus is on the complex technical issues and scope is typically multi-organizational and/or multi-site and /or involving outside resources. Functions: Responsible for providing technical guidance, Provide reports, data analysis and ensure flow of communication between technical groups including following up on and resolving issues that arise. Resolve technical issues and troubleshoot for assays as necessary, Ensure lab compliance – which includes implementing procedures that enhance GMP, GLP and safety. Manage existing and/or develop and implement new programs, processes and methodologies, Develop, revise and audit various complex controlled documents that may have multi-organizational and/or multi-site impact. Approve lab investigations, Lead audit teams May serve as subject matter expert to develop technical training. May perform routine work in a specific area of responsibility as necessary. Represents the department/organization on various teams, Independently responsible for following through on multi-site action items. May interact with regulatory agencies regarding area(s) of responsibility including written responses. May resolve issues with outside resources. Performs special projects as requested by supervisor, May supervise employees as necessary to meet technical requirements.
Education/Licenses: Doctorate degree or Master’s degree & 3 years of directly related experience or Bachelor’s degree & 5 years of directly related experience or Associate’s degree & 10 years of directly related experience or High school diploma / GED & 12 years of directly related experience.

Competencies/Skills: Understand, support and demonstrate the Client values. Excellent communication skills, facilitation and presentation skills. Excellent technical writing skills. Strong computer operation skills including work processing, presentation, database and spreadsheet application skills, Excellent project management and organizational skills including the ability to independently understand, follow, implement complex instructions and follow assignments through to completion. Advanced skill in handling multiple responsibilities, tasks and projects simultaneously including ability to shift priorities. Excellent knowledge of and experience with processes involved in quality analytical labs, validation, manufacturing, quality assurance, process development and distribution.

Extensive knowledge of all testing including the development and validation of assays and the ability to perform all testing in specific area of responsibility. Knowledge of pharmaceutical processes, Strong knowledge of U.S. regulations and practices pertaining to the testing of pharmaceutical/biological products. Knowledge of basic international regulations and practices pertaining to the testing of pharmaceutical/biological products Extensive knowledge and application of GMPs/CFRs. Ability to evaluate compliance issues. Skill in evaluating and documenting according to Company and various guidelines. Proficient at maintenance, troubleshooting and operation of equipment in area of expertise. Advanced scientific data analysis and interpretation skills. Advanced skills in solving complex problems. Advanced data trending and evaluation. Strong skill in working independently and to effectively interact with various levels. Ability to interact with regulatory agencies both orally and in writing. Initiate, coordinate and lead cross functional teams. Excellent skill in leading, motivating, influencing, and negotiating

Process Development Scientist – (29666)
Juncos, PR

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Administrative Shift – Non-Standard Shift

Doctorate degree Sciences/Engineering or Master’s degree in Sciences/Engineering and 3 years of directly related experience or Bachelor’s degree in Sciences/Engineering and 5 years of directly related experience.

(Biology, Biochemistry or Chemistry Preferred) or Engineering (Chemical or Mechanical Engineering Preferred)

Administrative hours and non-standard shift if needed (extra hours, weekend & holidays).
Experience supporting manufacturing operations in the following areas:

1. Formulation of Oral Parenteral Products
2. Vial Filing Process
3. Syringe Filling Process

The resources will provide day-to-day support to the commercial operations. Typical activities that will be conducting are:

1. On the floor support/troubleshooting activities of the formulation and filling process. Therefore experience in these areas is a must.
2. Provide support to investigations by participating in the root cause analysis, and providing product impact assessments
3. Own investigations and process monitoring assessments (knowledge of process monitoring, statistical knowledge and proficient in the use of minitab or JMP will be required)
4. Lead characterization activities by developing the design of the studies, protocol, training and execution of the characterization protocol
5. Excellent technical writing skills
6. Fully bilingual (Spanish/English)- A portion of the interview will be conducted in English to evaluate the candidates

Description:

To conceive, design, implement and execute specific scientific experiments, which contribute to the successful completion of goals and/or projects under general guidance of supervisor. Under general guidance of supervisor, Conceives and designs, executes or evaluates, and interprets experimental strategies. Provides input to new processes to generate robust and reliable data. Ensures that studies are conducted in compliance with the respective protocol and applicable guidelines and regulations. Designs, monitors or conducts experimental strategies with general guidance from supervisor. Provides data analysis and interpretation, and assesses impact of the data on the project. Keeps current in field of scientific expertise and areas relevant to their function. Monitors field of expertise, including literature and technology development, and communicates relevant observations. May introduce advanced scientific methods. Develops and implements new and novel protocols to address specific issues. May represent the department on project teams under supervision of a senior scientific staff member. May initiate productive collaborations within and outside of the department or company. Advises or assists others in experimental design and/or interpretation/diagnosis of data and implementing innovative remedies. Independently authors scientific reports, summary documents, complex regulatory documents, invention disclosure submissions and/or patents. Participates in external scientific community. May assume lead role in department-wide support efforts such as safety, recruiting and committees. May develop supervisory and mentoring skills. Develops and follows timelines for completing project team work.

Doctorate degree or Master’s degree and 3 years of directly related experience or Bachelor’s degree and 5 years of directly related experience or Associate’s degree and 10 years of directly related experience.

COMPETENCIES/SKILLS Advanced scientific analysis and troubleshooting skills.
Advanced laboratory work skills. Ability to motivate and/or supervise the activities of others.
Must be well organized, have multi-task project experience, and be able to communicate and work well with other departments. Must have demonstrated skills and competencies in the following areas: Verbal communication Written communication including technical writing skills, negotiation and conflict resolution Analytical problem solving Project management Ability to be flexible and manage change. Computer literacy (Windows environment: Word, Excel, Power Point). Skills requiring the application of scientific theory. Creative skills in the design and performance of scientific experiments and interpretation of results. Strong knowledge of cGMP’s. Fully bilingual (English/Spanish).

Process Development Scientist – (29648)
Juncos, PR

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Master’s degree in Sciences/Engineering and 3 years of related experience or Bachelor’s degree in Sciences/Engineering and 5 years of directly related experience.
Relevant work experience in data analysis or related field (eg as a statistician, data scientist, computational biologist, bioinformatician)
Work with large, complex data sets. Solve difficult, non-routine analysis problems, applying advanced analytical methods as needed. Conduct end-to-end analysis that includes data gathering and requirements specifications, processing, analysis, ongoing deliverables, and presentations
Experience with statistical software (e.g. R, MATLAB, SAS, Jump, Minitab) and database languages (e.g. SQL)
Experience with statistical data analysis such as linear models, multivariate analysis, and stochastic models
Experience articulating business questions and using mathematical techniques to arrive at an answer using available data
Demonstrated skills in selecting the right statistical tools given a data analysis problem

Data system knowledge – OSIsoft PI / Spotfire/ OVDAS
Description:
To conceive, design, implement and execute specific scientific experiments, which contribute to the successful completion of goals and/or projects under general guidance of supervisor. Under general guidance of supervisor, Conceives and designs, executes or evaluates, and interprets experimental strategies. Provides input to new processes to generate robust and reliable data. Ensures that studies are conducted in compliance with the respective protocol and applicable guidelines and regulations. Designs, monitors or conducts experimental strategies with general guidance from supervisor. Provides data analysis and interpretation, and assesses impact of the data on the project. Keeps current in field of scientific expertise and areas relevant to their function. Monitors field of expertise, including literature and technology development, and communicates relevant observations. May introduce advanced scientific methods. Develops and implements new and novel protocols to address specific issues. May represent the department on project teams under supervision of a senior scientific staff member. May initiate productive collaborations within and outside of the department or company. Advises or assists others in experimental design and/or interpretation/diagnosis of data and implementing innovative remedies. Independently authors scientific reports, summary documents, complex regulatory documents, invention disclosure submissions and/or patents. Participates in external scientific community. May assume lead role in department-wide support efforts such as safety, recruiting and committees. May develop supervisory and mentoring skills. Develops and follows timelines for completing project team work.
Doctorate degree or Master’s degree and 3 years of directly related experience or Bachelor’s degree and 5 years of directly related experience or Associate’s degree and 10 years of directly related experience.

COMPETENCIES/SKILLS Advanced scientific analysis and troubleshooting skills.
Advanced laboratory work skills. Ability to motivate and/or supervise the activities of others.
Must be well organized, have multi-task project experience, and be able to communicate and work well with other departments. Must have demonstrated skills and competencies in the following areas: Verbal communication
Written communication including technical writing skills, negotiation and conflict resolution Analytical problem solving Project management Ability to be flexible and manage change. Computer literacy (Windows environment: Word, Excel, Power Point). Skills requiring the application of scientific theory. Creative skills in the design and performance of scientific experiments and interpretation of results. Strong knowledge of cGMP’s. Fully bilingual (English/Spanish).

Sr Validation Scientist – (29649)
Juncos, PR

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Doctorate degree or Master’s degree and 3 years of validation experience or Bachelor’s degree and 5 years of validation experience.
Validation expertise
Sterilization
Kaye Validator & Data loggers
Process Validation
Equipment Qualification
Computer System Validation
Technical Writing

Independently provides and/or directs the technical validation engineering support of process and/or equipment upgrades, replacements, and modifications in the laboratory, manufacturing or manufacturing support environment. Able to troubleshoot systemic validation issues. Applies advanced and diverse validation engineering principles to the design and implementation of major system or process modifications and/or capital projects. Develops, organizes, analyzes and presents interpretation of results for operational issues or validation engineering projects of significant scope and complexity. Complete complex or novel assignments requiring development of new and/or improved validation engineering techniques and procedures. Develop validation engineering policies and procedures that affect multiple organizational units. Supervise, coordinate and review work of a small staff of engineers and/or technicians on an ongoing basis as well as on a project basis. Employ advanced validation engineering techniques and/or modifications of advanced techniques within area of validation engineering expertise. Apply knowledge of validation engineering principles and practices outside of area of expertise to broad variety of assignments in related fields. Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity. Work with manufacturing, process development, utilities, facilities, labs, and/or quality assurance in developing requirements and recommendations for large and/or highly complex process, system/facility modifications. Work with project managers to complete the validation responsibilities of engineering projects within schedule, budget and quality constraints. Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project. Prompt and regular attendance to the workplace.
*Other functions may be assigned
Knowledge:
Advanced validation knowledge (equipment qualification, cleaning, sterilization).
Applies extensive technical validation expertise, and has full knowledge of other related disciplines.
Problem Solving:
Provide technical solutions to a wide range of difficult problems. Solutions are imaginative, thorough, practicable, and consistent with organization objectives.
Discretion/Latitude:
Exercises considerable latitude in determining technical objectives of assignment. Completed work is reviewed from a relatively long- term perspective, for desired results.
Supervision and guidance relate largely to overall objectives, critical issues, new concepts, and policy matters.
Impact:
Essential to the completion of broad programs and projects.
Decisions, recommendations and actions form the basis of site/local program schedules and personnel/fiscal resource utilization.
Leadership:
Leads efforts of group of peers directly supervises staff or project resources.
Guides the successful completion of major programs and may function in a project leadership role.
May be expected to directly supervise staff or project resources.
Liaison:
Represents the organization as the prime technical contact on contracts and projects. Interacts with senior external personnel on significant technical matters often requiring coordination between organizations.
Regulatory:
Understands regulatory trends in industry and able to make connection between those trends and established corporate direction. Some direct experience with FDA or equivalent regulatory body.
Represents the organization as the technical expert to endorse the organization’s validation programs and practices

EDUCATION/LICENSES
Doctorate degree or Master’s degree and 3 years of directly related experience or Bachelor’s degree and 5 years of directly related experience or Associate’s degree and 10 years of directly related experience.
COMPETENCIES/SKILLS
In-depth knowledge of validation processes and requirements
Interacts effectively with variety of communication and working styles
Ability to independently determine when additional internal resources are required to solve problems
Ability to handle multiple projects at one time
Demonstrated Skills in the following areas:
Schedule development
Facilitation
Collaboration
Basic project management
Completion and follow-up
Technical expertise areas of validation engineering.
Ability to independently determine when additional external resources are required to solve problems
Ability to provide solutions to a large variety of technical problems of moderate to large complexity and scope
Problem solving skills requiring the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach.
Working knowledge of financial analysis tools
Ability to delegate and manage the project work of others
Demonstrated Skills in the following areas:
Negotiation, persuasion and facilitation
Collaboration
Project cost development
Conflict Resolution
Decision Making
Leadership and teambuilding
Management of contractors and vendors

Specialist Product Quality – (29625)
Juncos, PR

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Basic Qualifications

• Doctorate degree, or
• Master’s degree & 3 years of Quality, Operations, Scientific, or Manufacturing experience, or
• Bachelor’s degree & 5 years of Quality, Operations, Scientific, or Manufacturing experience
Preferred Qualifications
• B.S. or advance degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field and experience with growing responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment·

• Experience in stability and quality.

As a Specialist Stability you will provide support to the Product Quality (PQ) organization as a subject matter expert of clinical and commercial product stability studies and GMP data management. In this team-based role, you will directly add to the success of a Product Quality Team by collaborating with diverse functional areas including Supply Chain, Manufacturing, Quality Control, Regulatory, Quality Assurance, Quality Engineering, International Quality and Process Development on projects, issue resolution and investigations.
The Specialist Stability builds and monitors stability studies within quality systems (e.g. LIMS), owns and handles product quality and stability data and may serve as a primary author on regulatory filings and directly participate in and support site-based GMP inspections. Additional responsibilities include business process support, such as SOP authoring and management, or gap assessments to regional regulations. Expertise in project management, time management and successfully navigation skills for matrixed team environments are essential.
Client offers the opportunity to be at the interface between research, global development, and manufacturing to ensure that our molecules become medicines. Many of the technologies we are employing are not only new to Client but are new to the industry. Help us to pave new roads for helping patients.
Key Responsibilities include:
• Build and maintain technical GMP documents and product stability studies
• Review, verify, report, and archive GMP data for clinical and commercial products
• Apply keen attention to detail to conduct data review and reports
• Execute transactions in relevant GMP computer-based systems (change control, LIMS, etc.)
• Adeptly manage time-sensitive activities independently
Basic Qualifications
• Doctorate degree, or
• Master’s degree & 3 years of Quality, Operations, Scientific, or Manufacturing experience, or
• Bachelor’s degree & 5 years of Quality, Operations, Scientific, or Manufacturing experience
Preferred Qualifications
• B.S. or advance degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field and experience with growing responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment
• Experience working in a regulated environment (either direct GMP or technical support)
• Strong project management skills
• Understanding of biologic and synthetic pharmaceutical bulk and drug product manufacturing and analytical techniques
• General knowledge of cGMP and US and international filing regulations pertaining to the manufacture and testing of pharmaceuticals and/or bio-pharmaceuticals
• Experience working on a cross-functional team in a matrix environment
• Excellent written and verbal communication skills, including facilitation and presentation skills

Sr. Validation Scientist – (29641)
Juncos, PR

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Doctorate degree in Sciences/Engineering or Master’s degree in Sciences/Engineering and 3 years of validation experience or Bachelor’s degree in Sciences/Engineering and 5 years of validation experience or Associate’s degree and 10 years of directly related experience.
Experience in validation and in aseptic room classification. Knowledge in Media Fills and Air Visualization studies is desirable.

Position is for a first shift, but flexibility is required as necessary for the 2nd and 3rd shift on occasions related to validation process that may need to be covered in all shifts.

Description:
Independently provides and/or directs the technical validation engineering support of process and/or equipment upgrades, replacements, and modifications in the laboratory, manufacturing or manufacturing support environment. Able to troubleshoot systemic validation issues. Applies advanced and diverse validation engineering principles to the design and implementation of major system or process modifications and/or capital projects. Develops, organizes, analyzes and presents interpretation of results for operational issues or validation engineering projects of significant scope and complexity. Complete complex or novel assignments requiring development of new and/or improved validation engineering techniques and procedures. Develop validation engineering policies and procedures that affect multiple organizational units. Supervise, coordinate and review work of a small staff of engineers and/or technicians on an ongoing basis as well as on a project basis. Employ advanced validation engineering techniques and/or modifications of advanced techniques within area of validation engineering expertise. Apply knowledge of validation engineering principles and practices outside of area of expertise to broad variety of assignments in related fields. Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity. Work with manufacturing, process development, utilities, facilities, labs, and/or quality assurance in developing requirements and recommendations for large and/or highly complex process, system/facility modifications. Work with project managers to complete the validation responsibilities of engineering projects within schedule, budget and quality constraints. Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project. Prompt and regular attendance to the workplace.

*Other functions may be assigned

Knowledge:
Advanced validation knowledge (equipment qualification, cleaning, sterilization).
Applies extensive technical validation expertise, and has full knowledge of other related disciplines.

Problem Solving:
Provide technical solutions to a wide range of difficult problems. Solutions are imaginative, thorough, practicable, and consistent with organization objectives.

Discretion/Latitude:
Exercises considerable latitude in determining technical objectives of assignment. Completed work is reviewed from a relatively long- term perspective, for desired results.
Supervision and guidance relate largely to overall objectives, critical issues, new concepts, and policy matters.

Impact:
Essential to the completion of broad programs and projects.
Decisions, recommendations and actions form the basis of site/local program schedules and personnel/fiscal resource utilization.

Leadership:
Leads efforts of group of peers directly supervises staff or project resources.
Guides the successful completion of major programs and may function in a project leadership role.
May be expected to directly supervise staff or project resources.

Liaison:
Represents the organization as the prime technical contact on contracts and projects. Interacts with senior external personnel on significant technical matters often requiring coordination between organizations.

Regulatory:
Understands regulatory trends in industry and able to make connection between those trends and established corporate direction. Some direct experience with FDA or equivalent regulatory body.
Represents the organization as the technical expert to endorse the organization’s validation programs and practices

EDUCATION/LICENSES
Doctorate degree or Master’s degree and 3 years of directly related experience or Bachelor’s degree and 5 years of directly related experience or Associate’s degree and 10 years of directly related experience.

COMPETENCIES/SKILLS
In-depth knowledge of validation processes and requirements
Interacts effectively with variety of communication and working styles
Ability to independently determine when additional internal resources are required to solve problems
Ability to handle multiple projects at one time
Demonstrated Skills in the following areas:
Schedule development
Facilitation
Collaboration
Basic project management
Completion and follow-up
Technical expertise areas of validation engineering.
Ability to independently determine when additional external resources are required to solve problems
Ability to provide solutions to a large variety of technical problems of moderate to large complexity and scope
Problem solving skills requiring the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach.
Working knowledge of financial analysis tools
Ability to delegate and manage the project work of others
Demonstrated Skills in the following areas:
Negotiation, persuasion and facilitation
Collaboration
Project cost development
Conflict Resolution
Decision Making
Leadership and teambuilding
Management of contractors and vendors

Project Manager – (29645)
Juncos, PR

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Doctorate degree OR Master’s degree and 2 years of Project Management experience OR Bachelor’s degree and 4 years of Project Management experience.
Experience seeing projects through the full life cycle
Strong interpersonal skills and extremely resourceful
Proven ability to complete projects according to outlined scope, budget, and timeline.

Description:

“SUMMARY
Oversee, manage and coordinate all operational aspects of ongoing department projects impacting multiple departments. Serves as liaison between project team and department.

FUNCTIONS
1. Manage all aspects of project(s): planning, implementation, monitoring, completion, and follow-up.
2. Manage competing timelines and prioritize critical tasks. Establish and achieves project standards for work quality and quantity.
3. Assess project issues and develop solutions to meet scientific, productivity, quality and client satisfaction goals and objectives.
4. Assist in technical, financial, and organizational issues by researching issues, providing recommendations and maintaining document archives.
5. Maintain and track project budget(s).
6. Reconcile the use of resources for the projects.
7. Identify and anticipate schedule slips or changes and analyzes the costs and resource impact.
8. Implement tools, techniques and processes to provide or create information to enable informed decision making within the teams.
9. Actively participate in directing the evolution and defining the role of the project
10. Ensure the project goals and objects are well understood by the various functional areas.
11. Liaison with department staff, sub or satellite team leaders and members to obtain their continued input and feedback on the benefits, needs, and issues associated with the project.
12. Maintain the master project plan and schedule for assigned projects.
13. Recommend and develop operational or process improvements for the performance and successful functioning of the project team.
14. Provide department management with project management support on an as needed basis as well as for special projects.
15. May manage and direct the activities of project support staff
16. Conduct annual performance reviews, and provides career counseling and general guidance.
17. Identify or lead focus area projects within the overall function of project management or related projects.
18. Generate periodic updates and prepare formal presentations for required forums.
19. Generate individual and more complex reports utilizing various resources.
20. Ensure project work complies with domestic (may also involve international) regulatory requirements and approved guidelines relevant to area of responsibility.
21. Ensure project work complies with practices, policies and standard operating procedures.
22. Participate in required meetings, activities, and related projects and relevant interdepartmental activities.
23. Anticipate resource needs and communicate to management sponsors.

• Other functions that may be assigned.

EDUCATION
Doctorate degree OR Master’s degree and 2 years of Project Management experience OR Bachelor’s degree and 4 years of Project Management experience.

PREFERRED QUALIFICATIONS
• Skills in handling multiple responsibilities, priorities, tasks, and projects simultaneously.
• Skills in working under time pressure, and effectively in a team matrix environment.
• Practical project management software and spreadsheet skills, proficient computer operation skills.
• Effective interactions in a team or matrixes environment.
• Good organizational skills, detail-oriented & accurate, analytical skills.
• Team player, self-starter, persistent, tactful, and persuasive.
• Effective verbal and written communication skills (writing and presentations).
• Ability to assume increasing levels of responsibility.

Sr. Computer Validation Specialist – (28246)
Las Piedras, PR

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Qualifications:

Bachelor’s degree in engineering, computer science or related field. 5 years Experience with validating computer and Automation Systems in Manufacturing equipment such as Blenders, Tablet Press, Granulators, Encapsulators, Film Coaters. Technical writing skills for the creation of protocols. Team working – Work in teams to gather and analyze data and Protocol Execution, Keen attention to detail – Must be able to quickly spot when something isn’t correct and take effective action. Good communication skills – This role requires working with people from across the manufacturing process and often working with production staff to discuss projects, adherence to protocols and implementing. Excellent written communication – Documentation is essential requirement for compliance with emphasis in attention to details creating documentation. Prioritization skills – Working with project deadlines and ensuring the manufacturing process is working efficiently at every stage, must be able to prioritize workload.

Responsibilities:

SME for Generation and execution of CSV protocols. The Computer Systems Validation (CSV) position will develop and execute protocols and test scripts. This person is responsible for writing GxP computer validation and 21 CFR Part 11 and Data Integrity related documentation such as assessments, plans, URS, FRS, RTM, UATs, OQs and summary reports.

Specialist Quality Control – (29599)
Juncos, PR

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Doctorate degree in Sciences or Master’s degree in Sciences & 3 years of Quality experience or Bachelor’s degree in Sciences & 5 years of Quality experience.
Quality systems (Change Control, CAPA, Deviations) management and ownership
Project management experience
Validation experience
Temperature chambers knowledge
Office suite, MS Project
Excellent organization and communication skills

Description:

Under general direction, functions as the technical specialist for testing & development in areas of molecular biology and microbiology. Focus is on the complex technical issues and scope is typically multi-organizational and/or multi-site and /or involving outside resources. Functions: Responsible for providing technical guidance, provide reports, data analysis and ensure flow of communication between technical groups including following up on and resolving issues that arise. Resolve technical issues and troubleshoot for assays as necessary, ensure lab compliance – which includes implementing procedures that enhance GMP, GLP and safety. Manage existing and/or develop and implement new programs, processes and methodologies, Develop, revise and audit various complex controlled documents that may have multi-organizational and/or multi-site impact. Approve lab investigations, Lead audit teams May serve as subject matter expert to develop technical training. May perform routine work in a specific area of responsibility, as necessary. Represents the department/organization on various teams, independently responsible for following through on multi-site action items. May interact with regulatory agencies regarding area(s) of responsibility including written responses. May resolve issues with outside resources. Performs special projects as requested by supervisor, may supervise employees as necessary to meet technical requirements. Education/Licenses: Doctorate degree or master’s degree & 3 years of directly related experience or bachelor’s degree & 5 years of directly related experience or Associate’s degree & 10 years of directly related experience or High school diploma / GED & 12 years of directly related experience.
Competencies/Skills: Understand, support and demonstrate the Client values. Excellent communication skills, facilitation and presentation skills. Excellent technical writing skills. Strong computer operation skills including work processing, presentation, database and spreadsheet application skills, Excellent project management and organizational skills including the ability to independently understand, follow, implement complex instructions and follow assignments through to completion. Advanced skill in handling multiple responsibilities, tasks and projects simultaneously including ability to shift priorities. Excellent knowledge of and experience with processes involved in quality analytical labs, validation, manufacturing, quality assurance, process development and distribution.

Extensive knowledge of all testing including the development and validation of assays and the ability to perform all testing in specific area of responsibility. Knowledge of pharmaceutical processes, Strong knowledge of U.S. regulations and practices pertaining to the testing of pharmaceutical/biological products. Knowledge of basic international regulations and practices pertaining to the testing of pharmaceutical/biological products
Extensive knowledge and application of GMPs/CFRs. Ability to evaluate compliance issues. Skill in evaluating and documenting according to Company and various guidelines. Proficient at maintenance, troubleshooting and operation of equipment in area of expertise. Advanced scientific data analysis and interpretation skills. Advanced skills in solving complex problems. Advanced data trending and evaluation. Strong skill in working independently and to effectively interact with various levels. Ability to interact with regulatory agencies both orally and in writing. Initiate, coordinate and lead cross functional teams. Excellent skill in leading, motivating, influencing, and negotiating

Specialist Quality Complaints – (29600)
Juncos, PR

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Master’s degree in Sciences/Engineering & 3 years of experience in compliance/Investigation or Bachelor’s degree in Sciences/Engineering & 5 years of experience in compliance/investigation.
Experience in Complaint Investigation, Root Cause Analysis, and fluent in English.

Proposed shifts may include: M-F 8AM-5PM / M-F 2PM-11PM / K-S 8AM-5PM / M-SU 8AM-5PM.

Non-Standard Shift

Description:
Primary responsibilities include: Supporting the product complaint system at Client through; leading and managing product complaint investigations, performing data analysis and trending of complaint information to proactively detect signals and take appropriate actions in a timely manner. Functions: Keep the complaints database updated as soon as factual information is available and summarize closed investigations into the database accurately. Ensure complaint related investigations are concise, clear and science-based by reviewing and approving such investigations.
Follow-up on corrective actions derived from investigations through completion. On occasion, depending on the nature and complexity of the complaint, the specialist may be responsible of conducting and documenting the investigation. Therefore, the candidate must possess excellent writing skills that include closing the gap between a highly technical investigation into a simple and concise document that can be understood by non-technical reviewers. May also include: Communication and escalation of complaints, site representation on the product complaint network and generation and issuance of closure letters to patients and business partners.
Education/Licenses: Doctorate degree or Master’s degree & 3 years of experience directly related to the job or Bachelor’s degree & 5 years of experience directly related to the job

COMPETENCIES/SKILLS:
Strong project management skills, experience leading cross-functional teams, and the ability to handle multiple projects simultaneously is a must.
Excellent written and verbal communication skills, including facilitation and presentation skills.
Able to work in a team-oriented, matrix environment and work effectively with diverse departmental groups
Be self-motivated, able to interface effectively with various levels, attentive to details and able to prioritize and meet deadlines, and must possess excellent leadership, problem solving, analytical, influencing and customer service skills to operate and deliver results in a matrix-managed GMP environment.
Computer literacy, independently understand, follow and implement instructions, work independently or as a team player and collaborate with outside resources, and the ability to evaluate issues, make decisions and determine when to escalate, as necessary.

Sr. Specialist QA – (29602)
Juncos, PR

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Available to work Standard business hours and at times available for 2nd shift operations and weekend support Standard business hours and at times available for 2nd shift operations and weekend support

Doctorate degree in Science/Engineering and 2 years of Quality experience or Master’s degree in Sciences/Engineering and 6 years of Quality experience or Bachelor’s degree in Science/Engineering and 8 years of Quality experience

• Experience being in a Person-in-Plant role
• Experience using Quality Management systems (deviation, change control, CAPAs, EVs, supplier investigations) and SAP
• Self-starter, works independently & a corporate professional that can navigate at all levels of organization and with external suppliers
• Objective and the ability to manage root cause investigations and corrective actions in a timely manner, good communication skills (live discussions, emails, presentations, etc), good story telling skills to appropriately document investigations and follow up in Quality Management Systems
• Flexible and comfortable working with ambiguity, can manage multiple priorities with deadlines, knows when to escalate issues, has an Client-first mindset but can also represent suppliers to the internal org
• Knowledge of the biopharm manufacturing process, knowledge of the drug commercialization process, knowledge of GXPs, understands a regulated environment
• Patient first mentality, Quality mindset, self-awareness, works well in cross-functional teams
• The top three skills I’m looking for: 1) Leadership skills, 2) ability to think strategically and manage tactical, 3) does not sacrifice quality and regulatory requirements in any way

Available to work Standard business hours and at times available for 2nd shift operations and weekend support Standard business hours and at times available for 2nd shift operations and weekend support

Description

n support of Client’s Quality Assurance program acts as the technical specialist. Review and approve product MP’s.
Approve process validation protocols and reports for mfg. Processes. Represent Quality on incident triage team.
Approve Environmental Characterization reports. Release of sanitary utility systems. Approve planned incidents.
Represent QA on NPI team. Lead investigations. Own site quality program procedures. Designee for QA manager on local CCRB.
Doctorate degree and 2 years of directly related experience or Master’s degree and 6 years of directly related experience or Bachelor’s degree and 8 years of directly related experience or Associate’s degree and 10 years of directly related experience.
COMPETENCIES/SKILLS Project management skills. Strong organizational skills, including ability to follow assignments through to completion. Initiate and lead cross functional teams
Enhanced skills in leading, influencing, and negotiating. Strong knowledge in area of expertise. Collaborate and coordinate with higher level outside resources. Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation, and processes development. Demonstrated ability to interact with regulatory agencies. Strong word processing, presentation, database and spreadsheet application skills.
Strong communication (both written and oral), facilitation and presentation skills. Strong skill in working independently and to effectively interact with various levels. Advanced data trending and evaluation. Ability to evaluate compliance issues. Demonstrate the Client Values/Leadership Practices. Ability to independently determine when additional internal resources are required to solve problems, Schedule development, Facilitation, Collaboration, Basic project management, Completion and follow-up.

Project Manager – (29545)
Juncos, PR

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Doctorate degree OR Master’s degree and 2 years of Project Management experience OR Bachelor’s degree and 4 years of Project Management experience.

• Knowledge of supply chain planning, scheduling, master data and procurement processes
• Facilitation and presentation skills
• Strong analytical problem-solving skills
• Strong technical writing skills
• Strong project management skills
• Change management skills
• Ability to influence staff and effect change outside of area of responsibility
• Initiate and lead cross-functional teams to resolve complex issues
• Good decision-making skills
• Technical expert for function
• Possess an understanding and appreciation of the Client Values and Leadership Attributes
• Skills in handling multiple responsibilities, priorities, tasks, and projects simultaneously.
• Skills in working under time pressure, and effectively in a team matrix environment.
• Effective interactions in a team or matrixes environment.
• Good organizational skills, detail-oriented & accurate, analytical skills.
• Team player, self-starter, persistent, tactful, and persuasive.
• Effective verbal and written communication skills (writing and presentations).
• Ability to assume increasing levels of responsibility.
• Motivated self-starter who is able to change in an ambiguous environment
• Fluent English and Spanish (verbal and written)
• Good negotiation skills
• Proven ability to deliver results
• GMP and GXP knowledge
• Experience with audit processes including CAPA, etc.
• Experience with change control system and processes as change owner
• Experience improving processes
• Able to work autonomously
• Able to work under pressure
• Teamwork oriented
• Validation and Qualification Knowledge
• Experience in Pharmaceutical industry

General Requirements

Oversee, manage and coordinate all operational aspects of ongoing department projects impacting multiple departments. Serves as liaison between project team and department.

FUNCTIONS

1. Manage all aspects of project(s): planning, implementation, monitoring, completion, and follow-up.
2. Manage competing timelines and prioritize critical tasks. Establish and achieves project standards for work quality and quantity.
3. Assess project issues and develop solutions to meet scientific, productivity, quality and client satisfaction goals and objectives.
4. Assist in technical, financial, and organizational issues by researching issues, providing recommendations and maintaining document archives.
5. Maintain and track project budget(s).
6. Reconcile the use of resources for the projects.
7. Identify and anticipate schedule slips or changes and analyzes the costs and resource impact.
8. Implement tools, techniques and processes to provide or create information to enable informed decision making within the teams.
9. Actively participate in directing the evolution and defining the role of the project
10. Ensure the project goals and objects are well understood by the various functional areas.
11. Liaison with department staff, sub or satellite team leaders and members to obtain their continued input and feedback on the benefits, needs, and issues associated with the project.
12. Maintain the master project plan and schedule for assigned projects.
13. Recommend and develop operational or process improvements for the performance and successful functioning of the project team.
14. Provide department management with project management support on an as needed basis as well as for special projects.
15. May manage and direct the activities of project support staff
16. Conduct annual performance reviews, and provides career counseling and general guidance.
17. Identify or lead focus area projects within the overall function of project management or related projects.
18. Generate periodic updates and prepare formal presentations for required forums.
19. Generate individual and more complex reports utilizing various resources.
20. Ensure project work complies with domestic (may also involve international) regulatory requirements and approved guidelines relevant to area of responsibility.
21. Ensure project work complies with practices, policies and standard operating procedures.
22. Participate in required meetings, activities, and related projects and relevant interdepartmental activities.
23. Anticipate resource needs and communicate to management sponsors.

EDUCATION
Doctorate degree OR Master’s degree and 2 years of Project Management experience OR Bachelor’s degree and 4 years of Project Management experience.

PREFERRED QUALIFICATIONS
• Skills in handling multiple responsibilities, priorities, tasks, and projects simultaneously.
• Skills in working under time pressure, and effectively in a team matrix environment.
• Practical project management software and spreadsheet skills, proficient computer operation skills.
• Effective interactions in a team or matrixes environment.
• Good organizational skills, detail-oriented & accurate, analytical skills.
• Team player, self-starter, persistent, tactful, and persuasive.
• Effective verbal and written communication skills (writing and presentations).
• Ability to assume increasing levels of responsibility.

(RESUME BANK) Project Manager

Puerto Rico

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Location: Puerto Rico
Primary Responsibilities:
• Coordinate internal resources and third parties/vendors for the flawless execution of projects
• Ensure that all projects are delivered on-time, within scope and within budget
• Assist in the definition of project scope and objectives, involving all relevant stakeholders and ensuring technical feasibility
• Ensure resource availability and allocation
• Develop a detailed project plan to monitor and track progress
• Manage changes to the project scope, project schedule and project costs using appropriate verification techniques
• Measure project performance using appropriate tools and techniques
• Report and escalate to management as needed
• Manage the relationship with the client and all stakeholders
• Perform risk management to minimize project risks
• Establish and maintain relationships with third parties/vendors
• Create and maintain comprehensive project documentation
• Meet with clients to take detailed ordering briefs and clarify specific requirements of each project
• Delegate project tasks based on junior staff members’ individual strengths, skill sets and experience levels
• Track project performance, specifically to analyze the successful completion of short and long-term goals
• Meet budgetary objectives and make adjustments to project constraints based on financial analysis
• Develop comprehensive project plans to be shared with clients as well as other staff members
• Use and continually develop leadership skills
• Attend conferences and training as required to maintain proficiency
• Perform other related duties as assigned
• Develop spreadsheets, diagrams and process maps to document needs
Minimum Qualifications:
• Education: Bachelor’s degree in Architecture, Engineering or Construction Management
• Experience: At least 4 years of Construction Project Management
Preferred Qualifications:
• Certification: Project Management Professional (PMP) certification (preferred)
• OSHA 30-hour certification
• Computer literacy (Microsoft Office – Word, Excel, and PowerPoint, Outlook, Internet, etc.).
• Specific software literacy (Primavera 3/6, MS Project, AutoCAD, Viewpoint, BIM, Revit).
• Must have excellent documentation and organizational skills.
• Knowledge of acceptable site practices including OSHA Safety Regulations.
• Ability to communicate with both internal and external clients and co-workers.
• Have a thorough working knowledge of Project Management requirements.

(RESUME BANK) Project Engineer

Puerto Rico

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We are seeking available Project Engineer contractors who would like to be considered for project opportunities in 2020 and would like to be added to our resume database.

Location: Puerto Rico
Primary Responsibilities:
• Completes engineering projects by organizing and controlling project elements.
• Develops project objectives by reviewing project proposals and plans and conferring with management.
• Determines project responsibilities by identifying project phases and elements, assigning personnel to phases and elements, and reviewing bids from contractors.
• Determines project specifications by studying product design, customer requirements, and performance standards.
• Completes technical studies and prepares cost estimates.
• Confirms product performance by designing and conducting tests.
• Determines project schedule by studying project plan and specifications, calculating time requirements, and sequencing project elements.
• Maintains project schedule by monitoring project progress, coordinating activities, and resolving problems.
• Controls project plan by reviewing design, specifications, and plan, scheduling changes, and recommending actions.
• Controls project costs by approving expenditures and administering contractor contracts.
• Prepares project status reports by collecting, analyzing, and summarizing information and trends; recommending actions.
• Maintains safe and clean working environment by enforcing procedures, rules, and regulations.
• Maintains project data base by writing computer programs; entering and backing up data.
• Maintains product and company reputation by complying with federal and state regulations.
• Contributes to team effort by accomplishing related results as needed.

inimum Qualifications:
• Education: Bachelor’s degree in Architecture, Engineering or Construction Management
• Experience: At least two years of experience in the construction field.

Preferred Qualifications:
• OSHA 30-hour certification
• Highly proficient in use of Microsoft Office
• Strong organizational / time management skills
• Familiar to proficient with construction software (Bluebeam, MS Project or P6)
• Construction trade / jobsite knowledge / familiarity (Contract documents and drawings, cost estimating, construction jobsite / field experience, equipment / materials)

(RESUME BANK) Process Development Scientist

Puerto Rico

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BS in Engineering (preferred in Mechanical or Chemical Engineering) or Life Sciences (preferred on Biology, Chemistry, Microbiology) and 5 years of Scientific experience.
Experience in Vial or Syringe Filling, Isolator Technology, Vial or Syringe Filling Characterization, Vial or Syringe Filling Validation.

To conceive, design, implement and execute specific scientific experiments, which contribute to the successful completion of goals and/or projects under general guidance of supervisor. Under general guidance of supervisor, Conceives and designs, executes or evaluates, and interprets experimental strategies. Provides input to new processes to generate robust and reliable data. Ensures that studies are conducted in compliance with the respective protocol and applicable guidelines and regulations. Designs, monitors or conducts experimental strategies with general guidance from supervisor. Provides data analysis and interpretation and assesses impact of the data on the project. Keeps current in field of scientific expertise and areas relevant to their function. Monitors field of expertise, including literature and technology development, and communicates relevant observations. May introduce advanced scientific methods. Develops and implements new and novel protocols to address specific issues. May represent the department on project teams under supervision of a senior scientific staff member. May initiate productive collaborations within and outside of the department or company. Advises or assists others in experimental design and/or interpretation/diagnosis of data and implementing innovative remedies. Independently authors scientific reports, summary documents, complex regulatory documents, invention disclosure submissions and/or patents. Participates in external scientific community. May assume lead role in department-wide support efforts such as safety, recruiting and committees. May develop supervisory and mentoring skills. Develops and follows timelines for completing project team work.

Doctorate degree or Master’s degree and 3 years of directly related experience or Bachelor’s degree and 5 years of directly related experience or Associate’s degree and 10 years of directly related experience.

COMPETENCIES/SKILLS Advanced scientific analysis and troubleshooting skills. Advanced laboratory work skills. Ability to motivate and/or supervise the activities of others. Must be well organized, have multi-task project experience, and be able to communicate and work well with other departments. Must have demonstrated skills and competencies in the following areas: Verbal communication Written communication including technical writing skills, negotiation and conflict resolution Analytical problem-solving Project management Ability to be flexible and manage change. Computer literacy (Windows environment: Word, Excel, Power Point). Skills requiring the application of scientific theory. Creative skills in the design and performance of scientific experiments and interpretation of results. Strong knowledge of cGMP’s. Fully bilingual (English/Spanish).

(RESUME BANK) Sr. Computer Validation Specialist

Puerto Rico

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Qualifications:

Bachelor’s degree in engineering, computer science or related field. 5 years’ Experience with validating computer and Automation Systems in Manufacturing equipment such as Blenders, Tablet Press, Granulators, Encapsulators, Film Coaters. Technical writing skills for the creation of protocols. Team working – Work in teams to gather and analyze data and Protocol Execution, Keen attention to detail – Must be able to quickly spot when something isn’t correct and take effective action. Good communication skills – This role requires working with people from across the manufacturing process and often working with production staff to discuss projects, adherence to protocols and implementing. Excellent written communication – Documentation is essential requirement for compliance with emphasis in attention to details creating documentation. Prioritization skills – Working with project deadlines and ensuring the manufacturing process is working efficiently at every stage, must be able to prioritize workload.

Responsibilities:

SME for Generation and execution of CSV protocols. The Computer Systems Validation (CSV) position will develop and execute protocols and test scripts. This person is responsible for writing GxP computer validation and 21 CFR Part 11 and Data Integrity related documentation such as assessments, plans, URS, FRS, RTM, UATs, OQs and summary reports.

(RESUME BANK) Quality Control Scientist

Puerto Rico

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• Technical evaluation of chemical analytical methods to determine reagents / equipment to be used, assure acquisition and deployment, develop and/or revise analytical methods Quality Standards documents.
• Determine and delineate proper implementation of the analytical methods (method transfer, validation or verification). Prepare method validation protocols, determine specifications, data evaluation, and execution of final reports and assure proper laboratory deployment of the method.
• Reports / collects / evaluates laboratory data to support cleaning process implementation.
• Coordinates / delineates / conduct laboratories works in collaboration with Quality Laboratory Analysts to collect / generate the necessary data, data evaluation and prepare the corresponding reports to support conclusions and recommendations according to the tasks assigned.
• Perform other job-related tasks as required.
• Comply with all safety and environmental guidelines, procedures, training, practices, permit conditions, and internal notification of any safety and environmental events.

Education and/or Experience:

Bachelor Degree in Science with Chemistry major (preferably).
Five (5) or more years processing experiences in Quality Control or Technical Operations is preferred or equivalent combination of education and experience.
The incumbent must have experience in product introduction and transfer, developing and validating analytical methods demonstrating skills necessary to build and maintain a high-performance.
Willing to work irregular and/or extended shifts if needed.
Able to work under pressure with minimum supervision and able to meet deadlines.

Computer Knowledge/Specific Skills:

Knowledge of Good Manufacturing Practice regulations, EPA regulations, Laboratory Safety Rules, OSHA regulations, classical and modern analytical chemistry or microbiology and sophisticated instrumental techniques.
Work experience with Office (Word, Excel, PowerPoint, and Outlook).
Minitab or any other statistical application.

(RESUME BANK) QA Specialist

Puerto Rico

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• Bachelor’s degree in Life Science or Engineering and 5 years of Manufacturing or Quality in GMP regulated environment experience.
• Project management skills
• Strong organizational skills, including ability to follow assignments through to completion
• Collaborate and coordinate with higher level outside resources
• Strong knowledge of and experience with processes involved in manufacturing, QA, QC, validation and process development
• Demonstrate ability to interact with regulatory agencies
• Strong word processing, presentation, database and spreadsheet application skills
• Strong skill in working independently and to effectively interact with various levels
• Ability to evaluate compliance issues

Description:

Perform one or more of the following duties and responsibilities in support of Client’s Quality Assurance program under minimal supervision. Review and approve product MPs. Approve process validation protocols and reports for manufacturing processes. Request Quality on incident triage team. Approve Environmental Characterization reports. Release of sanitary utility systems. Approve planned incidents. Represent QA on NPI team. Lead investigations. Lead site audits. Own site quality program procedures. Designee for QA manager on local CCRB. Review Risk Assessments. Support Automation activities. Support facilities and environmental programs. Review and approve Work Orders. Review and approve EMS/BMS alarms. Approve NC investigations and CAPA records. Approve change controls. Provide lot disposition and authorize lots for shipment.

Doctorate degree or Master’s degree and 3 years of directly related experience or Bachelor’s degree and 5 years of directly related experience or Associate’s degree and 10 years of directly related experience.

COMPETENCIES/SKILLS Project management skills, Strong organizational skills, including ability to follow assignments through to completion, Initiate and lead cross functional teams, Enhanced skills in leading, influencing and negotiating, Strong knowledge in area of expertise, Collaborate and coordinate with higher level outside resources, Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development, Demonstrate ability to interact with regulatory agencies, Strong word processing, presentation, database and spreadsheet application skills, Strong communication (both written and oral), facilitation and presentation skills, Strong skill in working independently and to effectively interact with various levels, Advanced data trending and evaluation
Ability to evaluate compliance issues, Demonstrate the Client Values/Leadership Practices.

(RESUME BANK) Sr. Automation Engineer

Puerto Rico

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Qualifications:
• Bachelor’s Degree in Engineering or Computer Science Required:
• Subject Matter Expert on PLC/SCADA system code development, testing, qualification.
• Good communication skills.
• Ability to participate in and lead highly effective teams.
• Ability to become influential in his/her area demonstrated by suitable technical degrees and/or experience.
• Ability to work with all levels of business customers in a highly dynamic environment.
• Strong leadership and interpersonal skills in motivating staff and customers in the achievement of shared objectives.
• High personal integrity, credibility, and energy.
• Ability to integrate diverse initiatives across systems development groups, business and client organizations, and infrastructure areas.
• Experience and in-depth understanding of System Development Life Cycle (SDLC) and application systems development.
• Good project management experience in relation to scope, cost, and schedule control of large automation capital projects.
• A minimum of 3 years manufacturing or related experience is required.
• Experience with automation systems for pharmaceutical facilities is required.
• In-depth understanding of System Development Life Cycle (SDLC) and applications systems development is required. Preferred:
• A minimum of 10 years in automation is strongly preferred.
• Experience and accomplishments in the project management of manufacturing automation/ execution systems.
• Other information technology experience is a plus

Responsibilities:

Automation project support role for various scale manufacturing automation projects to ensure the projects are delivered of high quality. This includes following the project through multiple phases of a project life-cycle including requirements, design, testing, installation, qualification and training. It will involve working closely with the customer, technical staff, other engineering groups and the management of suppliers to ensure a successful implementation. Major Projects include automating production of key Client products in all three areas of Manufacturing.

Projects will be for Human Health Pharmaceutical facilities and employing technologies including: Supervisory Control and Data Acquisition Systems (SCADA)
•Manufacturing Execution Systems (MES)
•Process Data Management Systems
•IT Integration Services The candidate could also serve as the Automation/IT Project Manager on a small sized project, to ensure that the project is delivered within cost and on schedule. The candidate must also understand the business needs of MMD and stay abreast of new technologies to make recommendations for business improvements. Candidate should be familiar with the application of SDLC Methodology and computer validation concepts. Candidate must possess good communication skills.

(RESUME BANK) Sr. Validation Scientist

Puerto Rico

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Bachelor’s degree in Life Sciences or Engineering and 5 years of Scientific experience OR Master’s Degree in Life Sciences or Engineering and 3 years of Scientific experience.
Cleaning and/or Sterilization knowledge.

Independently provides and/or directs the technical validation engineering support of process and/or equipment upgrades, replacements, and modifications in the laboratory, manufacturing or manufacturing support environment. Able to troubleshoot systemic validation issues. Applies advanced and diverse validation engineering principles to the design and implementation of major system or process modifications and/or capital projects. Develops, organizes, analyzes and presents interpretation of results for operational issues or validation engineering projects of significant scope and complexity. Complete complex or novel assignments requiring development of new and/or improved validation engineering techniques and procedures. Develop validation engineering policies and procedures that affect multiple organizational units. Supervise, coordinate and review work of a small staff of engineers and/or technicians on an ongoing basis as well as on a project basis. Employ advanced validation engineering techniques and/or modifications of advanced techniques within area of validation engineering expertise. Apply knowledge of validation engineering principles and practices outside of area of expertise to broad variety of assignments in related fields. Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity. Work with manufacturing, process development, utilities, facilities, labs, and/or quality assurance in developing requirements and recommendations for large and/or highly complex process, system/facility modifications. Work with project managers to complete the validation responsibilities of engineering projects within schedule, budget and quality constraints. Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project. Prompt and regular attendance to the workplace.