Continuous Process Verification defines this Validation Engineer II role at Thermo Fisher Scientific’s Whitby site. Analyze manufacturing data and support GMP validation activities.
Within the CPV team, you provide specialized validation expertise supporting operations, Process Pharmacy, and clients. The role covers manufacturing and packaging process validation across commercial pharmaceutical production. You will compile batch-record data, complete risk assessments, execute protocols, and review reports before final approval. The schedule is a 7 1/2 hr shift, with PPE and GMP safety standards required.
Key Responsibilities: Compile, review, verify, and analyze validation data
Prepare and execute manufacturing validation protocols
Write process and packaging validation reports
Coordinate validation activities with production scheduling
Support CPV investigations and process improvement studies
Requirements: Bachelor’s degree and two years’ GMP validation experience
Knowledge of cGMP, FDA regulations, ISO, and GAMP5
Solid technical writing, risk assessment, and gap analysis
Proficiency with Microsoft Office applications
Ability to manage multiple validation projects independently
Apply validation engineering, data analysis, and technical writing expertise to support CPV operations at Thermo Fisher Scientific in Whitby.