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Thermo Fisher Scientific Quality Process Validation Engineer in Cambridge, Massachusetts

Title: Quality Process Validation Engineer

Department: QAV

Status: Exempt

Reports to: Cambridge QAV Head VVS Cambridge

When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.

Location/Division Specific Information

Cambridge, MA

How will you make an impact?

At Viral Vector Services (VVS) a division of Thermo Fisher Scientific we deliver, from process development through commercial supply, we offer the expertise and resources necessary to help clients deliver innovative gene therapies. Placed in the forefront of our leading and cutting edge Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases.

What will you do?

Position Description/Summary:

  • Primary Duties of Quality Process Validation Engineer is to provide support to Manufacturing Sciences & Technology (MS&T) functions for the Brammer Bio Operations with focus at the Cambridge location.

  • Technical knowledge of continuous process validation of processes in the cGMP manufacturing space in order to provide quality oversight to manufacturing operation of equipment/systems.

  • Carries out duties in compliance with all local, state, and federal regulations and guidelines including the FDA, EU. Complies with all client site policies and procedures.

  • Support review and approval of generation of quality assurance policies and procedures related to process performance qualification

  • Review and approval of executed documents and deviations for process validation activities and in support of process performance qualifications.

  • Provide technical support on change controls, assessing new change controls for process equipment, automation systems that are proposed and all the requirements necessary to maintain a validated status.

  • Support interpret and implement quality assurance standards

  • Subject matter Expert responsible for maintaining change control system.

  • Provide QAV support and assessments on Process related change controls.

  • Review for execution approval of change controls per change control SOP and client agreement.

  • Assure ongoing compliance with quality and industry regulatory requirements

  • Participate in client audits and regulatory inspections by escorting auditors and securing requested documents and data

Responsibilities:

  • Own process validation studies as required and manage the project through to closure per timelines

  • Keep current on regulatory and quality requirements and follow Environment, Health and Safety policies

  • Review and approval of executed process validation protocols and other documentation for Gene Therapy process from cell culture through final fill

  • Review and approval of analyzed results and summarized process validation activities related to Stage 2 (Process Performance Qualification) and Stage 3 (Continued Process Verification)

  • Experience in late stage/commercial technology transfer, and process validation in the biopharmaceutical/gene transfer vector manufacturing areas.

  • Must have strong understanding of QBD, risk Based, and performing Quality Risk Assessments

  • Must have strong knowledge of 21 CFR, ICH Q9 & ICH Q10, and EU regulations, GAMP, ASTM-E2500.

  • Must be skilled in the use of a personal computers and related software

  • Must have strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.

  • Must be able to provide effective written or verbal communication to peers, senior associates, and area management within their operational group.

  • Must be able to recognize, understand and respond to situations requiring further evaluation and report these events (PROCESS, SAFETY, PERSONNEL) AREA MANAGEMENT.

  • Ability to function independently and ability to solve technical issues related to the deviations.

How will you get here?

Education, Experience

  • Bachelor's degree in Sciences/Engineering + 5 years relevant industry experience OR Master's degree in Sciences/Engineering + 3 years relevant industry experience required.

  • 6-8 years GMP experience preferred

  • Quality inspection, auditing and testing experience

  • Experience in late stage process characterization is desirable

Knowledge, Skills, Abilities

  • Knowledge of cell and gene therapy vector production is desirable

  • Experience in late stage process characterization is desirable

  • Strong interpersonal and communications skills; written and oral

  • Ability to work both independently and as part of a team

  • Ability to function in a fast-paced dynamic team environment and to prioritize across multiple projects

  • Excellent troubleshooting skills and ability to solve complex technical issues.

  • Quality inspection, auditing and testing experience

Physical Demands:

  • Ability to function in a dynamic environment and balance multiple priorities simultaneously

  • Ability to learn new software tools quickly

  • Ability to make decisions with minimal to moderate supervision

  • Ability to aseptically gown and /or sterile gown as needed

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com .

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

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