Engineer III, Validation

Thermo Fisher Scientific • Plainville, MA

3d • $134,202 - $138,900 • Onsite

About The Position

Thermo Fisher Scientific Inc. is seeking an Engineer III, Validation for their Plainville, MA location. This role involves performing comprehensive validation activities for clinical and commercial drug substance manufacturing of cell and gene therapy products. The position requires drafting, executing, reviewing, and approving various quality documentation, identifying compliance issues, analyzing validation data, and providing technical direction. The engineer will also evaluate regulations, participate in investigations and change controls, and lead CQV efforts. Support for internal and external inspections, driving quality system improvements, and authoring/maintaining SOPs and Validation Master Plans are key responsibilities. The role involves building relationships with other sites to promote validation best practices and defending validation methodologies during audits. Collaboration with various departments such as Manufacturing, Quality Assurance, and Engineering is expected. Travel up to 25% domestic and international is required.

Requirements

• Bachelor’s degree in Computer Engineering, Chemical Engineering, Electrical Engineering, or related field of study.
• 5 years of experience as a Validation Engineer, or related experience.
• 5 years of experience with drafting, reviewing SOP's.
• 5 years of experience within cGMP environment, including the ability to clean room gown.
• 5 years of experience with Detail cGMPs and organizational FDA/industry expectations.
• 5 years of experience with facility and utility qualification requirements in compliance with associated regulations.
• 3 years of experience with data integrity and 21CFR Part 11 regulations and application in both GMP manufacturing and analytical laboratories.
• 3 years of experience working on projects of moderate to high complexity in regards to compliance of processes and product within facilities, equipment manufacturing and support areas.
• 3 years of experience with cGMP equipment including, for example, isolators and aseptic filling machines, autoclaves, bioreactors, chromatography and TFF skids, analytical instruments.
• 2 years of experience with single use technology and/or process/facility design.

Responsibilities

• Perform validation activities including 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 areas where non-compliance or non-harmonization is occurring.
• Analyze data from validation tests to determine whether systems and processes meet required criteria and specifications.
• Provide technical direction to core teams and act as customer-facing lead for project teams.
• Evaluate current and new regulations, changes to existing regulations and regulatory trends; perform gap analysis to determine deficiencies and take appropriate actions.
• Participate in deviation investigations and support change control assessments related to manufacturing process equipment, utilities, automation, computer systems, validation, methods, and laboratory instruments.
• Lead and participate 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.
• Help drive continuous quality system improvements.
• Author and maintain CQV SOPs, Validation Master Plans and protocols.
• Requalification program development and execution.
• Prepare, review and approve production, validation, audit reports and/or master batch record documents, procedures, and rationale.
• Build and manage relationships with other WS sites to develop and promote validation standard methodologies and ensures compliance with Thermo Fisher (PCG/WS) SOP's.
• Defend policies, procedures, rationales and methods in the area(s) of expertise during regulatory and client audits.
• Collaborate with Manufacturing, Manufacturing Sciences, Quality Assurance, Quality Control, and other Engineering teams.
• Perform other projects and duties as assigned by the Validation Engineering Manager/Director for the overall benefit of Thermo Fisher.

Benefits

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

What This Job Offers

• Job Type: Full-time
• Career Level: Senior