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
- Robust 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.

📌 Validation Engineer II CPV (Whitby)
🏢 ThermoFisher Scientific
📍 Whitby