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

Validation Services
Guayama, PR

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The project consists of designing, installing, configuring, validating the new DC / AD and “moving” all of that equipment to that new DC / AD with the requirements and policies ofthe new company.

Resources will be working in the complete validation cycle, except generation of Change Control, according to the client’s procedures, which typically include: Impact Assessment, ERES Assessment, Validation Plan, URS, DS, FS, DS, Traceability Matrix, IOQ, IOA Report, VP Report.

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 Scientist – (29806)
Juncos, PR

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

Bachelor’s degree in Science (Statistics, Biology, Biochemistry, Math or Chemistry Preferred) or Engineering (Industrial Engineering Preferred).
Work on the Process Monitoring (Continue process verification) for Parenteral and Solid products. Provide support to investigations by participating in the root cause analysis. Own/lead investigations and corrective action implementations.

Requisites: Knowledge on parenteral and solid processes (Formulation, Granulation, Filling, Compression, Coating, etc.). Statistical knowledge and proficient in the use of Minitab and JMP, R-coding recommended. Knowledge in data retrieval/data analysis/presentation tools (OsiSoft PI, Spotfire, Smartsheet, Tableau etc), as well as MS Office (including Excel, Word and PowerPoint). Excellent technical writing skills. Fully bilingual (Spanish/English)- A portion of the interview will be conducted in English to evaluate the candidate.

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’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 – (29814)
Juncos, PR

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

•Engineering / Science related background.
•Experienced in Aseptic processing manufacturing processes.
•General understanding on Manufacturing Execution Systems (MES) and electronic Batch Records (e-BR).

Experience working on GMP regulatory and compliance manufacturing environments with a strong Quality mindset in the production of aseptically produced sterile biological drug products.

•Direct experience on Quality related matters associated to the GMP sustainability of pharmaceutical production areas.
•Capable to review and approve complex GMP documents from a Quality standpoint to ensure adherence to company policies, operating standards, procedures and/ or the applicable GMP document or project plan.
•Ability to conduct GMP quality inspections, walk downs and general oversight to production, utilities and general facility areas with the objective to ensure the required state of Validation.
•Knowledge on general Validation concepts (e.g. Process Performance Qualifications, Commissioning & Qualification and Validation Life Cycle Management for Equipment and Facilities including Computerized Systems) applied to GMP Pharmaceutical production areas required.
•Direct experience supporting multifaceted Validation projects from a Quality perspective and working with multidisciplinary teams on tight execution schedules.
•Ability to analyze, troubleshoot and solve quality related issues on a highly regulated GMP environment.
•General understanding around the process for the introduction of new products and new technology within commercial GMP areas.
•Ability to communicate and escalate quality issues clearly, with the required level of details and on a timely manner.
•Demonstrated ability to follow GMP procedures with a strong Quality and Compliance mindset.
•Project Management skills. Presentation Skills.
•Excellent Technical Writing and general Communication skills in English and Spanish.
•Information/Computer Systems knowledgeable.
•Good interaction skills to enable appropriate performance supporting complex matrix organizations.
•Capable to follow required Environmental Health & Safety procedures and related requirements within a GMP production environment.
•Ability to learn, execute and follow procedures related to Personnel Gowning for access to environmental controlled/classified rooms.
•Experience conducting quality audits to GMP production batch records and related supporting operational compliance documents for review and approval.
•Ability to work in teams and demonstrate full engagement with execution plans and adherence to established due dates.

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.

Automation Projects Engineer
Barceloneta, PR

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This role will support Client to ensure that the local business own computer systems and automation equipment are operational through system enhancements and projects. The scope includes automation systems and equipment that supports manufacturing, packaging, engineering and utilities and other similar systems. The resource will be primary focus on small projects and system enhancements, however, bigger projects could require support from this role.

The position will reports to a manager level or technical lead level with moderate supervision. It will not have internal direct reports however may lead contractors during projects or similar activities.

Project management skills and experience is a most (certified PMP preferred). Strong automation technical knowledge: PLC, SCADA, BMS, Process Control, Manufacturing and Packaging systems; Solid understanding of cGMP’s, FDA regulations and Computer System Validation philosophy. Good exposition on GXP quality and compliance environment (pharmaceutical), especially automation related and computer validation. Fully bilingual (English, Spanish).

CQ Specialist- Full Time – Exempt
North area, PR

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The role is responsible to support and lead all aspect of the Commissioning and Qualification (C&Q) program Life Cycle from design through operation and maintenance. The role will develop and manage the commissioning and qualification program of the site. The resource will assure the compliance with cGMP, GAMP and ISPE guidelines. The role is responsible to prepare site validation documentation such as User requirements, design and functional specifications, qualification protocols, master plans, risk assessments, periodic reviews, among others. The resource will coordinate the work of contractors for multiple projects and will assure the projects are well documented in the site change control system. The resource could support for a limited time other functions such as project management and technical evaluations for the site.

A bachelor’s degree in Science such as Pharmacy, Engineering, Biotechnology, Chemistry, Physics or Biology. Minimum of 5 years of experience in a highly-regulated industry like Pharmaceuticals and/or Medical Device. Knowledge in cGMP, GAMP, ISPE and computerized system life cycle guidelines. Knowledge on site utilities (HVAC, Compressed air, Purified water, etc). and facility is required.

The position will help the site in completing Commissioning and Qualification activities for Project PCAS such as but not limited to: Area mappings, Blender qualifications, Environmental qualifications in PKG, etc.

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).

Specialist QA – (29689)
Juncos, PR

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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.

Sr Specialist QA – (29703)
Juncos, PR

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Doctorate degree in Science AND 2 years of directly related experience OR
Master’s degree in Science AND 6 years of directly related experience OR
Bachelor’s degree AND 8 years of directly related experience

Shift: Administrative hours primarily. But support during non-standard shifts may be required on a business need basis.

• Industrial Microbiologist, Environmental Microbiologist educational discipline is preferred.
• Experience working on GMP regulatory and compliance manufacturing environments with a strong Quality mindset in the production of sterile biological products.
• Experience conducting trending, monitoring an oversight of cleaned, controlled and classified environments for sterile and non-sterile manufacturing areas.
• Proficient establishing environmental control procedures and assessing adequate gowning systems to personnel interacting within controlled environments.
• Capable to troubleshoot contamination events and determine action plans, propose compliant solutions to address complex contamination control problems and develop expert protocols to mitigate quality and operational contamination situations (e.g. cleaning and sanitation procedures, disinfectants implementation and qualification, microbiological samplings and techniques for adequate contamination control prevention).
• Capable of solving problems related to microbial growth within industrial pharmaceutical controlled environments.
• Apply statistical tools and methodologies in the process of conducting environmental control trending and monitoring analysis.
• Capable to conduct scientific data gathering, analysis, interpretation and reporting of expert technical documents intended to diagnose the state of microbiological control of facilities and critical utilities (e.g. water for injection).
• Project Management Skills.
• Presentation Skills.
• Information/Computer Systems knowledgeable.
• Good interaction skills to enable appropriate performance supporting complex matrix organizations.

Description:

In support of Amgen’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.

Sr Validation Scientist – (29796)
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 Sciences/Engineering and 5 years of directly related experience or Associate’s degree and 10 years of directly related experience.

Assembly, Tester and Packaging processes and machines support; Basic knowledge and experience on Medical Device/Combo Product processes and regulations; Basic metrology and testing experience; Validation and Characterization experience (Protocols/URS/DS/IOQ/PQ); Basic project management skills; Basic experience in medical device assembly process; Technical Report writing skills; Basic statistical knowledge; Basic Machine troubleshooting; Basic automation knowledge (PLC, HMI, Drivers, Motors, Profibus, Device Net, Control Net); Able to work in any shift as required by the projects and activities.

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

Specialist QA – (29797)
Juncos, PR

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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 services supporting Warehouse and Incoming operations as well as knowledge in ERP and QMTS systems (deviations, CAPA, Change Control) are preferred.

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.

Ingeniero Licenciado o Arquitecto Licenciado
Vega Baja, PR

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Vasta experiencia en las siguientes funciones/responsabilidades:

Experiencia trabajando proyectos relacionados con Fondos Federales.
Planificador de proyecto como de los recursos a cargo.
Integrador de los esfuerzos de las distintas áreas del Programa , para que participen en el proyecto.
Comunicador y mantener el interés por el proyecto y la oportuna acción de las diferentes áreas del programa.
Asesorar y capacitará a los integrantes del equipo de trabajo del Proyecto designado por el Director de Programa.
Deberá poner énfasis en lo técnico relacionado al proyecto y también en lo cotidiano e institucional para lograr las metas del proyecto.
Deberá definir los objetivos del proyecto, estos deberán ser claros y alcanzables según las capacidades del Programa y los fondos de recuperación.
Deberá alinear el proyecto con la estrategia del programa.
Tendrá la responsabilidad de administrar los costos y presupuestos.
Será responsable de la calidad del proyecto según los estándares de desempeño definido y de la industria.
Rendirá informes continuos de resultados y status del proyecto al Director del Programa, sobre los avances o retrasos del proyecto y realizará un seguimiento para el cumplimiento de las fechas estipuladas sobre los avances o retrasos del proyecto.
El gerente cumplirá con los tres parámetros más importantes, (calidad, costo y tiempo) a que se enfrentan todos los proyectos ejerciendo la administración adecuada.
Coordinará los recursos para lograr terminar el proyecto a tiempo.
Garantizará y coordinará que todo el personal relacionado al proyecto reciba toda la información necesaria.
Analizará y manejará los riesgos que se presentan y el manejo las comunicaciones a través del Director del Programa.

Technical Operations Specialist – Scope of Work
North Region

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North Region – Temporary Exempt Status
Education and/or Experience

• Should have Tablet Coating expertise using a Fully or partially perforated Coating Pan.
• List the minimum academic credentials and/or years of experience
• A bachelor’s degree in Science such as Pharmacy, Engineering, Biotechnology, Chemistry, Physics or Biology; a graduate degree such as M.Sc. or Ph.D. is recommended for advancement.
• Minimum of 5 years of experience in a highly – regulated industry like Pharmaceuticals and/ or Medical Devices.
• Indicate to hitch licenses or professional certifications are required or preferred (Ex. ABC, preferred).
• Licensed Pharmacist, Licensed Chemical or Professional Engineer Licensed, preferred.

Technical Operations Specialist – Scope of Work
North Region

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North Region – Temporary Exempt Status
Education and/or Experience

• Should have Tablet press expertise, especially double layer in a fetter machine.
• List the minimum academic credentials and/or years of experience
• A bachelor’s degree in Science such as Pharmacy, Engineering, Biotechnology, Chemistry, Physics or Biology; a graduate degree such as M.Sc. or Ph.D. is recommended for advancement.
• Minimum of 5 years of experience in a highly – regulated industry like Pharmaceuticals and/ or Medical Devices.
• Indicate to hitch licenses or professional certifications are required or preferred (Ex. ABC, preferred).
• Licensed Pharmacist, Licensed Chemical or Professional Engineer Licensed, preferred.

Quality Scientist – Scope of Work
North Region

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North Region – Temporary Exempt Status
Education and/or Experience
List the minimum academic credentials and/or years of experience.

• Bachelor’s Degree in Science, Microbiology.
• Minimum of (5) five years of experience in the Pharmaceutical Industry in Microbiology Fields (i.e. Validations, Laboratory).
• Certified Quality Engineer, preferred.
• Completely bilingual (English & Spanish).
• Able to move between areas.
• Willing to travel when it is required and support other facilities.

IT CSV Consultant
South PR Region

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The project consists of designing, installing, configuring, validating the new DC / AD and “moving” all of that equipment to that new DC / AD with the requirements and policies of the new company.

Resources will be working in the complete validation cycle, except generation of Change Control, according to the client’s procedures, which typically include: Impact Assessment, ERES Assessment, Validation Plan, URS, DS, FS, DS, Traceability Matrix, IOQ, IOA Report, VP Report.

Sr Project Manager – (29700)
Juncos, PR

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Administrative Shift
Doctorate degree and 2 years of Project Management experience OR Master’s degree in and 4 years of Project Management experience OR Bachelor’s degree or and 6 years of directly Project Management.
• 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.
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).

Sr Validation Scientist – (29717)
Juncos, PR

MORE DETAILS

Master’s degree and 3 years of Sciences/Engineering experience or Bachelor’s degree in Engineering/Sciences and 5 years of Engineering experience.
• Working knowledge of pharmaceutical/biotech processes
• Working knowledge with validation processes
• Working knowledge with documentation in a highly regulated environment
• Ability to operate specialized laboratory equipment and computers as appropriate.
• Ability to interpret and apply GLPs and GMPs.
• Ability to apply engineering science to production.
• Able to develop solutions to routine technical problems of limited scope
• Demonstrated skills in the following areas:
o Problem solving and applied engineering.
o Basic technical report writing
o Verbal communication
• Comprehensive understanding of validation protocol execution requirements.
• Demonstrated Skills in the following areas:
o Basic technical presentations
o Personal Organization
o Validation Protocol Writing
o Dealing with and managing change
o Technical (Equipment Specific)
o Analytical Problem Solving
o Computer Literacy
• Specialized equipment/process expertise
• In-depth knowledge of validation processes and requirements as applied to new equipment installations
• 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:
o Schedule development
o Facilitation
o Collaboration
o Basic project management
o Completion and follow-up
• Established expertise in at least 3 separate areas of engineering technology.
• 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:
o Negotiation, persuasion and facilitation
o Collaboration
o Project cost development
o Conflict Resolution
o Leadership and teambuilding
• Basic knowledge in vision systems
• Basic knowledge in equipment controls (PLC, HMI, Servodrives, etc)
• Basic knowledge in Medical Devices or Combination Products
• Basic knowledge in Lean Manufacturing, Six Sigma or Quality by Design
• Basic knowledge in Statistics
• Basic knowledge in Metrology
• Basic knowledge in plastic molding process
• Basic knowledge of medical device assembly process
• Basic knowledge of packaging of medical devices or pharmaceutical products
• Basic knowledge in Safety Training (MSDS, Equipment Safety, etc)

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

Process Development Scientist – (29721)
Juncos, PR

MORE DETAILS

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.

Shift: Non-Standard
• Supporting the development of User Requirements Specifications of equipment
• Support the commissioning and qualification of new and existing assets
• Support the characterization of new or existing assets, identifying boundary limits, critical parameters, developing the testing strategy and statistical sampling plans
• Provide support in investigations and the proposal and implementation of corrective actions related to investigations
• Ensure activities follow cGMP procedures and are documented according to cGMP requirements including assigned training
• Apply lean six sigma, operational excellence and continues improvement in assigned projects.
• Develop business cases for new or modifications to existing systems, to determine feasibility based on business needs, including but not limited to demand, capacity, logistics, space, financial impact and head count
• Writing of test protocols, perform technical evaluations and testing to support reports used to justify the use of selected materials and packaging components

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).

Validation Scientist – (29724)
Juncos, PR

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Master’s degree in Sciences/Engineering or Bachelor’s degree in Sciences/Engineering & 2 years of directly related experience.
Installation, Commissioning, Characterization and Validation of Computerized based Packaging Equipment’s.

Description:
Under general supervision, provides direct technical validation engineering support of process and/or equipment upgrades, replacements, and modifications in the laboratory, manufacturing, or manufacturing support environment. Able to troubleshoot basic validation issues. Applies basic validation engineering principles to the design and implementation of system or process modifications and/or capital projects. Organizes, analyzes and presents interpretation of results for operational issues or validation engineering projects of minor scope and complexity. Provide solutions to a variety of technical validation problems of moderate scope and complexity. Under general supervision will evaluate, select and apply standard validation engineering techniques and procedures. Assistance given for unusual problems. Perform assignments that have clear and specific objectives and require investigation of limited number of variables. Initiate and complete routine technical tasks. Function as a technical validation expert to equipment or systems regarding troubleshooting operations. Frequently become actively. Involved in daily operations when required to meet schedules or to resolve complex validation problems. Routinely audit the validation status and regulatory compliance of a moderate number of equipment items or systems of significant complexity. Work with manufacturing, maintenance, process development, utilities, facilities, labs, and/or quality assurance in developing requirements and recommendations for system modifications. Work under the direct supervision of project managers to complete the validation responsibilities of engineering, and construction projects within schedule and budget constraints. Generate rudimentary project cost estimates and schedules. Prompt and regular attendance to the workplace.. Master’s degree or Bachelor’s degree & 2 years of directly related experience or Associate’s degree & 6 years of directly related experience.

COMPETENCIES/SKILLS:
Working knowledge of validation processes and programs. Familiarity with pharmaceutical/biotech processes. Familiarity with documentation in a highly regulated environment. Ability to operate specialized laboratory equipment and computers as appropriate. Ability to interpret and apply GLPs and GMPs. Ability to apply validation engineering to production. Able to develop solutions to routine technical problems of limited scope. Demonstrated skills in the following areas: Problem solving and applied engineering. Basic technical report writing. Verbal communication. Computer Literacy. Comprehensive understanding of validation processes and programs. Demonstrated Skills in the following areas: Basic technical presentations. Personal Organization. Validation Protocol & Report Writing, Dealing with and managing change. Technical (Equipment Specific). Analytical Problem Solving.

Process Development Scientist – (29741)
Juncos, PR

MORE DETAILS

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.
Manual Visual Inspection and Automatic Visual Inspection processes, vision engineering, Cognex, vision systems, statistics (DOE, ANOVA).

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 – (29666)
Juncos, PR

MORE DETAILS

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).

Sr Specialist QA – (29815)
Juncos, PR

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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.
•Engineering / Science related background.
•Experienced in Aseptic processing manufacturing processes.
•General understanding on Manufacturing Execution Systems (MES) and electronic Batch Records (e-BR).

Experience working on GMP regulatory and compliance manufacturing environments with a strong Quality mindset in the production of aseptically produced sterile biological drug products.
•Direct experience on Quality related matters associated to the GMP sustainability of pharmaceutical production areas.
•Capable to review and approve complex GMP documents from a Quality standpoint to ensure adherence to company policies, operating standards, procedures and/ or the applicable GMP document or project plan.
•Ability to conduct GMP quality inspections, walk downs and general oversight to production, utilities, and general facility areas with the objective to ensure the required state of Validation.
•Knowledge on general Validation concepts (e.g. Process Performance Qualifications, Commissioning & Qualification and Validation Life Cycle Management for Equipment and Facilities including Computerized Systems) applied to GMP Pharmaceutical production areas required.
•Direct experience supporting multifaceted Validation projects from a Quality perspective and working with multidisciplinary teams on tight execution schedules.
•Ability to analyze, troubleshoot and solve quality related issues on a highly regulated GMP environment.
•General understanding around the process for the introduction of new products and new technology within commercial GMP areas.
•Ability to communicate and escalate quality issues clearly, with the required level of details and on a timely manner.
•Demonstrated ability to follow GMP procedures with a strong Quality and Compliance mindset.
•Project Management skills. Presentation Skills.
•Excellent Technical Writing and general Communication skills in English and Spanish.
•Information/Computer Systems knowledgeable.
•Good interaction skills to enable appropriate performance supporting complex matrix organizations.
•Capable to follow required Environmental Health & Safety procedures and related requirements within a GMP production environment.
•Ability to learn, execute and follow procedures related to Personnel Gowning for access to environmental controlled/classified rooms.
•Experience conducting quality audits to GMP production batch records and related supporting operational compliance documents for review and approval.
•Ability to work in teams and demonstrate full engagement with execution plans and adherence to established due dates.
•Strong engagement and partnership with site Management.

Description:
In 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.

Sr Validation Scientist – (29761)
Juncos, PR

MORE DETAILS

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

Highly preferred Chemical Engineer, Life Sciences (Microbiology, Chemistry, Natural Sciences, Biology, Biotechnology.
Must be fluent in English (speaking and writing), previous experience in product /process development and validation, if major experience of the candidate is in equipment validation does not qualify for this position (IQ, OQ, Computer, packaging, etc). Must have previous experience writing technical reports with science discussion.

Available to work in shift including 2nd, 3rd shifts and over the weekend when required.

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

(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.