Engineer III, Validation

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Commerce Blvd, Plainville, MA 02762 TITLE:                                     Engineer III, Validation HOURS:                                   Monday to Friday, 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. Travel: Up to 25% domestic and international travel required.

MINIMUM Education Requirement: Bachelor’s degree in Computer Engineering, Chemical Engineering, Electrical Engineering, or related field of study. MINIMUM Experience Requirement: 5 years of experience as a Validation Engineer, or related experience.   Required knowledge or experience with: 5 years of experience with following, 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