Engineer III, Validation

Work Schedule

Standard (Mon-Fri), 8:00 am to 5:00 pm

Duties

• 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
• 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 supports 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

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.

Required Knowledge or 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 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

Pay

$134,202 to $138,900 per year

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