Engineer III, Validation

Thermo Fisher Scientific • Plainville, MA

1d • Onsite

About The Position

Thermo Fisher Scientific is seeking an Engineer III, Validation for their Plainville, MA location. This role involves performing a wide range of validation activities for clinical and commercial drug substance manufacturing of cell and gene therapy products. The position requires identifying and addressing non-compliance, analyzing validation data, providing technical direction, and staying current with regulations. The engineer will participate in deviation investigations, support change control, and lead/participate in cross-functional teams for CQV efforts. Responsibilities also include authoring SOPs, Validation Master Plans, and protocols, managing relationships with other sites to promote validation best practices, and defending validation strategies during audits. Collaboration with various departments such as Manufacturing, Quality Assurance, and Quality Control is essential. The role may involve up to 25% domestic and international travel.

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 drafting and reviewing SOP's.
• 5 years of experience within a cGMP environment, including the ability to clean room gown.
• 5 years of experience with detailed 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 (URS, Commissioning protocols, IOQs, PQs, Re-qualifications, Periodic Reviews, Final Reports, Validation project plans, Investigations, and Risk Assessments).
• Identify areas of non-compliance or non-harmonization.
• Analyze data from validation tests to determine if 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 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 timeframes for project implementations.
• Support internal and external inspections.
• Drive continuous quality system improvements.
• Author and maintain CQV SOPs, Validation Master Plans, and protocols.
• Develop and execute requalification programs.
• Prepare, review, and approve production, validation, and audit reports, master batch record documents, procedures, and rationale.
• Build and manage relationships with other WS sites to develop and promote validation standard methodologies.
• Ensure compliance with Thermo Fisher (PCG/WS) SOP's.
• Defend policies, procedures, rationales, and methods 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.

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
• Short- and long-term disability
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
• Employees’ Stock Purchase Plan (ESPP)

What This Job Offers

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