Thermo Fisher Scientific Validation Engineer III in Plainville, Massachusetts
When you join Thermo Fisher Scientific, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions.
Location/Division Specific Information
At the Plainville site within the Viral Vector Services (VVS), a division of Thermo Fisher Scientific, we deliver Advanced Therapeutics from process development through commercial supply, and we offer the expertise and resources vital to help clients deliver innovative gene therapies
How will you make an impact?
The Validation Engineer III will support the Commissioning, Qualification and Validation (CQV) program and will be the SME for those qualification activities. The role is responsible for cGMP compliance of facility, utilities and equipment validation and their execution for the VVS Plainville site and equipment lifecycle documentation policies and procedures supporting current Good Manufacturing Practices. The initial focus of the position will be supporting the execution of a large capital facility project from construction and operational readiness activities for a state-of-the-art new commercial manufacturing facility. This role will transition into primary manufacturing operations support role in the site Facilities and Engineering team where they will support manufacturing, laboratory, and warehouse operations.
What will you do?
In operations, you will be responsible for providing
Perform validation activities that include drafting, executing, reviewing, and approving quality documentation (User Requirement Specifications (URS), Commissioning protocols, IOQs, PQs, Re-qualifications, Periodic Reviews, Final Reports, Validation project plans, Investigations, and Risk Assessments) for clinical and commercial drug substance manufacturing of cell and gene therapy products
Identify any areas where non-compliance or non-harmonization is occurring
Participate in deviation investigations and supports change control assessments related to manufacturing process equipment, utilities, automation, computer systems, validation, methods, and laboratory instruments.
Leads and participates in multi-functional department teams for CQV efforts to meet established timeframe for project implementations that support business needs and meet global regulatory requirements.
Support internal and external inspections for the subject matter
Helps drive continuous quality system improvements
Crafts and maintains CQV SOPs, Validation Master Plans and protocols Requalification program development and execution
Builds and manages relationships with other VVS sites to develop and promote validation best practices and ensures compliance with Thermo Fisher (PCG/VVS) SOP’s
The position involves close collaboration with Manufacturing, Manufacturing Sciences, Quality Assurance, Quality Control, and other Engineering teams.
How will you get here?
- B.S. Degree required, preferably in an engineering discipline or related technical field
Experience and Skills
Minimum of 4 years of relevant validation experience
Direct experience supporting pharmaceutical manufacturing processes within an FDA/EMA environment highly desired
Experience in authoring, execution, performance, and summarizing qualification and validation activities including URS, SIA, QP, DQ, IQ, OQ, PQ, CSV & QSR and CAPA management
Previous experience working with temperature mapping software in a commercial operation
Knowledge, Skills, Abilities
Strong understanding of applicable regulatory requirements
Documentation review and revision experience
Strong interpersonal and communications skills; written and oral
Strong ability to work independently
Comfortable supporting concurrent issues and working in an exciting, ambitious, and fast-paced environment
High ethical standards to support a professional business code of conduct
As the world leader in serving science and with the largest investment in R&D in the industry, you will be empowered to realize your full potential as part of a fast-growing, global organization that values your passion and unique contributions. Our commitment to you and our 80,000 colleagues is to provide the resources and opportunities you need to make a difference in our world while building an exciting career with us.
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.
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