Pharmaceutical process validation drives this Engineer II position at Thermo Fisher Scientific in Whitby. Use technical writing and data analysis within GMP operations.
Supporting a commercial manufacturing site and integrated pharmaceutical development services facility, you will work with the Continuous Process Verification team. Your responsibilities include validating manufacturing and packaging processes, analyzing executed batch records, and preparing controlled documentation. You will provide technical support to operations and Process Pharmacy while coordinating validation requirements with production schedules. The position may require alternating or rotating shifts and adherence to PPE and GMP safety standards. Client meetings, investigations, special studies, and support for other validation teams are included when required.
Key Responsibilities: Provide validation expertise and technical support to operations
Analyze executed batch-record data for CPV activities
Prepare validation protocols and final reports
Monitor schedules and coordinate validation requirements
Attend selected client meetings as validation representative
Requirements: Bachelor’s degree in engineering, life sciences, chemistry, or related field
Two years of validation experience in regulated environments
Knowledge of statistical analysis and process control methods
Transparent verbal and written communication skills
Experience with quality systems and validation documentation
Bring pharmaceutical validation, documentation, and process analysis capabilities to Thermo Fisher Scientific’s commercial Whitby manufacturing operations.