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

Cleaning/Process Validation Specialist

Barceloneta, PR

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Must have 5 plus years of Cleaning/Process validation experience in the pharmaceutical industry with Cleaning/Process validation.

Estimated contract of 6 months

Specialist QA (29332)

Juncos, PR

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Must be available for any shift as of per client business need & Must be Fully Bilingual (English & Spanish)
Master’s degree Sciences/Engineering and 3 years of directly related experience or Bachelor’s degree Science/Engineering and 5 years of directly related experience

Experience on the following: Quality Assurance, QC, Validation, Lab Equipment, Compliance, Investigations, Change Control, Technical support, or Regulatory reviewing and approving records. Experience with Aseptic Processing, Contamination Control or Programming is highly desirable.

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.

Process Development Scientist (29153)

Juncos, PR

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

• Perform experiments, organize data and analyze results under minimal supervision. This resource will identify and classify container defects and perform evaluations regarding primary packaging components.
• With minimal supervision plans, conducts or monitors experiments, records and organizes data, analyses results.
• Generates robust and reliable data in compliance with the respective protocol or SOPs.
• Experience using Microscope, calipers.
• Work in laboratory environment
• Good Documentation Practices
• Monitors or follows established experimental design and protocols and performs routine tasks and studies to obtain reproducible and reliable results with limited supervision.
• Plans, monitors or conducts, analyzes and records experiments, and provides interpretation of data.
• Participates in department-wide support efforts such as safety.
• Monitor and maintain inventory of supplies and sample inventory.

*Non-Standard Shift

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 teamwork.

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 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).

Supply Chain Manager (29228)

Juncos, PR

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Bachelor’s degree on Business Administration or Industrial Engineering and 5 years of related experiences, ideally in Supply Chain Management or Industrial Engineering.
Detail oriented
Strong project management and operational excellence background
Demonstrated verbal and written communication skills
Highly organized
Self-starter
Ability to follow assignments through to completion with little oversight.
Effectively interact with various internal and external clients in adherence with Client values
Supply Chain, Sourcing, or Procurement experience.

*****Administrative Shift *********
Description:
Under minimal supervision provides Supply Chain work group supervision and technical expertise in support of successfully completing daily operations within scope of responsibility. Ensures all work is completed with minimal disruption and in compliance with all cGMP guidelines and Client procedures. Direct and coordinate daily activities of personnel responsible for material receipt, storage and transport. Ensures materials are received, stored and transported according to established performance standards and all applicable procedures and regulations. Interacts with internal and external regulatory agencies to ensure compliance with cGMP, DOT, OSHA requirements. Collaborate with other sites to maintain optimal flexibility for the storage of all materials and product. Identify and oversee implementation of new and improved business and compliance systems and tools. Partner with key internal customer groups and/or external suppliers to ensure successful operations and performance targets are achieved.

Responsible for business continuity programs for assigned areas. Participate on global functional teams to coordinate and improve the transportation and Logistics of material movement and storage across the Client Supply Chain.

Direct and coordinate daily activities of personnel responsible for developing and managing Product demand and forecasts. Organize and communicate on a regular basis the total demand and supply requirements to senior management. Coordinate the Master Production Schedule for Finished Goods and effectively communicate any impact created by, and to the supply plan. Manage the process of gathering, evaluating and feedback of global demand requirements. Provide and coordinate the development of business case scenarios that demonstrate the impact of current or proposed operations plans. Manage the preparation and communication of the Company wide Inventory Distribution Plan to achieve corporate goals of customer satisfaction and risk management.
Develop and coordinate the long-range production requirements based on Marketing forecasts, product approval and release timelines, clinical requirements, SKU put-up information and business planning timelines estimates.

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

Must have well developed skills from Supervisor I level in addition to the following: 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, While performing the duties of this job, the environment for the staff member is of an office atmosphere. Computer terminals, telephones, and calculators are in use constantly. Assignments are received in task and objective oriented terms. Provides direction to subordinates using established policies and procedures. Work is reviewed upon completion for adequacy in meeting the task / objective. Administers policies and procedures that typically affect individual staff members within one or more functional work groups. Accomplishes tasks mainly through general supervision of nonexempt and experienced exempt employees. Monitors daily operations of a work group and actively assists, or provides direction to, subordinates as required. May perform ongoing operational tasks. Makes decisions regarding group operations. Erroneous decisions or recommendations or failure to achieve results might cause delays in program schedules and result in the allocation of more resources. Ensures tasks and projects are efficiently completed on schedule following established procedures and within budget. Majority of liaison is on internal basis with subordinates and supervisors at equivalent level or one level higher. Regularly conducts briefings to management. Liaison normally involves specific phases of a project or operation. External contacts are regular and generally involve coordinating operational issues.

Sr Project Manager – (29266)

Juncos, PR

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Bachelor’s degree in Life Sciences or Engineering and 2 years of Scientific experience OR Master’s Degree in Life Sciences or Engineering.
Project Management. Experience in Packaging, Formulation and Filling area (Mainly Packaging). Drug product Business cases execution/lead and support PD drug product New Product Introduction team. This can include Change Controls generation, project leads, presentations, among others. Must be fully bilingual and have good presentation skills.

Description:

“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.

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).

Data Entry Operator II

El Paso, Texas

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Purpose of Position:

Performs routine data entry work. Work involves entering data and maintaining files and documentation. Works under moderate supervision, with limited latitude for the use of initiative and independent judgment.

Location: El Paso, TX

Estimated start date: January 2020

Responsibilities:
• Performs data entry and verification of data files.
• Transcribes source documents to acceptable formats.
• Prepares formatting programs for most applications and corrects entry errors.
• May advise others on work procedures.
• May verify data entered by others.
• May operate control stations, tape drives, disk drives, or consoles.
• Performs related work as assigned.

Minimum Qualifications:
• Education: Graduation from high school or equivalent
• Experience in data entry work.
• Graduation from a standard senior high school or equivalent is generally preferred. Experience and education may be substituted for one another.

Preferred Qualifications:
• Other Language: Ability to proficiently read, write, and speak Spanish

Required Skills:
• Knowledge of data entry equipment and of office practices and procedures.
• Ability to detect and resolve error conditions, to select and transcribe data, and to communicate effectively.

Child Support Officer II

El Paso, Texas

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Purpose of Position:
Performs entry-level/routine child support work. Work involves conducting detailed investigations to locate absent parents, establishing paternity; enforcing court orders for child support and /or responding to customer inquiries.

Location: El Paso, TX

Estimated start date: January 2020

Responsibilities:
•Takes the appropriate case action to locate absent parents, establish paternity for children born out-of-wedlock, establish or enforce child/medical support obligation, or initiate case closure:

o Conducts detailed in-office investigations to locate parties, verify employment and determine assets
o Prepares documents relating to legal and administrative actions to establish or enforce child support orders
o Negotiates lump sum payments from noncustodial parents who owe past due child/medical support
o Negotiates out-of-court settlements and agreements with parties (CSO II only)
o Monitors child support cases and refers delinquent cases for the appropriate enforcement action(s)
o Documents all case actions taken using the appropriate agency tools, including but not limited to Texas Child Support Enforcement System (TXCSES), case/court documents
o Reviews and maintains child support virtual files for accuracy in the Enterprise Content Management (ECM) repository
o Reviews cases to determine if the cases are eligible for closure

• Attends court to assist legal staff, as needed
• Researches case information on the computer including TXCSES
• Maintains current knowledge of child support policies and procedures, Texas Family Law, federal regulations and other states= IV-D regulations
• Assesses child support cases to determine the appropriate case action
• Explains Child Support Program policies, procedures and regulations to customers
• Responds to customer inquiries and complaints
• Assesses the validity of complaints against the IV-D program with impartiality
• Serves as Notary Public
• Performs related work as assigned
• Maintains relevant knowledge necessary to perform essential job functions
• Attends work regularly in compliance with agreed-upon work schedule
• Ensures security and confidentiality of sensitive and/or protected information
• Complies with all agency policies and procedures, including those pertaining to ethics and integrity

Minimum Qualifications:
• Education: Bachelor’s degree from an accredited college or university; experience in the following (or closely related) fields may be substituted for the required education on a year-for-year basis: Child Support Program, credit collections, investigations, legal assistant, legal secretary, or IV-A eligibility specialist
• Experience: 0 years of full-time experience working in the following (or closely related) fields:
• Ability to type 35 words per minute (Typing test required at time of interview)
• Ability to receive and respond positively to constructive feedback
• Ability to work cooperatively with others in a professional office environment
• Ability to provide excellent customer service
• Ability to arrange for personal transportation for business-related travel
• Ability to work more than 40 hours as needed and in compliance with the FLSA
• Ability to lift and relocate 30 lbs.
• Ability to travel (including overnight travel) up to 15%

Preferred Qualifications:
• Knowledge: Investigative practices and techniques
• Other Language: Ability to proficiently read, write, and speak Spanish

Required Skills:
• Skill in interviewing and negotiating
• Skill in using a personal computer for word-processing and data entry/retrieval
• Skill in basic mathematical computations
• Skill in handling multiple tasks, prioritizing, and meeting deadlines
• Skill in effective oral and written communication
• Skill in exercising sound judgment and effective decision making

Assistant Attorney General II

El Paso, Texas

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Purpose of Position:
Performs attorney work for the Child Support Division. Work involves representing the state’s interest in judicial and administrative matters, and providing legal advice, consultation and technical assistance to the Child Support Program and staff.

Location: El Paso, TX

Estimated start date: January 2020

Responsibilities:
• Represent the State of Texas at legal proceedings to locate, establish, enforce, modify or terminate court orders for child support and medical support.
• Represents the State of Texas in administrative hearings
• Provides legal advice, consultation and technical assistance to the Child Support Program.
• Develops and delivers training
• Performs related work as assigned.
• Maintains relevant knowledge necessary to perform essential job functions.
• Attends work regularly in compliance with agreed-upon work schedule.
• Ensures security and confidentiality of sensitive and/or protected information.
• Complies with all agency policies and procedures, including those pertaining to ethics and integrity.

Minimum Qualifications:
• Education: Graduation from an accredited law school with a Juris Doctor (J.D.) degree
• Licensed as an attorney by the State of Texas
• Member in good standing with the State Bar of Texas
• Experience: 1 year of full-time experience working as a licensed attorney
• Knowledge of Family Law and the Texas Family Code
• Works under moderate supervision, with limited latitude for the use of initiative and independent judgment.
• Ability to receive and respond positively to constructive feedback
• Ability to work cooperatively with others in a professional office environment
• Ability to provide excellent customer service
• Ability to arrange for personal transportation for business-related travel
• Ability to work 40 hours per week as needed and in compliance with the FLSA
•Ability to lift and relocate 30 lbs.
•Ability to travel (including overnight travel) up to 25%

Preferred Qualifications:
• Two years’ experience in handling Family Law cases
• Jury Trial Experience
• Experience in handling a high-volume legal practice
• Other Language: Ability to proficiently read, write, and speak Spanish

Required Skills:
• Skill in legal writing, mediation, and negotiation
• Skill in serving as a trial lawyer, preparing sound opinions, conducting investigations and performing legal research
• Skill in using a personal computer for word-processing and data entry/retrieval
• Skill in handling multiple tasks, prioritizing, and meeting deadlines
• Skill in effective oral and written communication
• Skill in exercising sound judgment and effective decision making

Design Engineers

Guaynabo, PR

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Design Engineers (structural, electrical, mechanical, architectural)

We are seeking contractors to support a global Construction organization located in Guaynabo, PR.

Available/Qualified contractors please provide a detailed and up to date MS Word format resume.

Requirements/Qualifications:
1) Licensed w/ active CIAPR registration
2) 5 years’ minimum experience with industrial project design
3) Bilingual (Spanish and English as base)
4) Dynamic, self-starter with leadership skills
5) Familiarized with the use of design software’s
6) Familiarized with the use of CAD & 3D software’s

(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) Project Manager

Puerto Rico

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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.
Supply Chain Management, Software Trackwise QMTS, Excel Intermediate/Advanced, Product Launches and Post Launch Variations.

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.

(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.