Job Title: CQV Engineer
Company: Intellectt Inc.
Location: Ontario, Canada
Employment Type: Contract : 12+ Months
Description:
Our client is seeking a CQV Validation Engineer to support commissioning, qualification, and validation activities within a GMP-regulated pharmaceutical manufacturing environment. The role involves executing qualification protocols, validating pharmaceutical manufacturing equipment and utility systems, and ensuring compliance with applicable GMP and regulatory requirements.
Job Responsibilities:
- Execute commissioning, qualification, and validation (CQV) activities for pharmaceutical manufacturing equipment, facilities, and utility systems.
- Develop, review, and execute IQ, OQ, and PQ protocols.
- Perform qualification of GMP utility systems, including HVAC, purified water (PW), Water for Injection (WFI), clean steam, and compressed air.
- Support equipment qualification, system walkdowns, functional testing, and field verification.
- Execute and document FAT and SAT activities.
- Prepare validation protocols, test scripts, execution reports, and qualification summary reports.
- Identify and document deviations, discrepancies, and protocol exceptions.
- Support change control, deviation management, and CAPA activities.
- Ensure qualification documentation meets GMP and regulatory requirements.
- Collaborate with Engineering, Quality Assurance, and Manufacturing teams.
Required Qualifications:
- Bachelor's degree in Mechanical, Chemical, Electrical, or a related Engineering discipline.
- 3+ years of CQV experience within the pharmaceutical or biotechnology industry.
- Hands-on experience executing IQ, OQ, and PQ protocols.
- Experience qualifying pharmaceutical manufacturing equipment and GMP utility systems.
- Knowledge of HVAC, PW, WFI, clean steam, and compressed air systems.
- Understanding of GMP, GAMP 5, and ASTM E2500 guidelines.
- Experience with FAT, SAT, deviations, and change control.
- Familiarity with Kneat, ValGenesis, or MasterControl is preferred.
Pay Scale: Anticipated hourly pay range: Based on experience and qualifications: CA$45 - CA$50
Benefits: To be determined based on applicable Canadian employment and benefit plans.
