We are seeking a CQV Engineer to support the qualification and validation of process equipment, utilities, and controlled environments within a GMP-regulated pharmaceutical manufacturing facility. The role focuses on ensuring systems are commissioned, qualified, and compliant with regulatory and quality standards.
Key Responsibilities
- Support qualification of upstream and downstream process equipment, including media and buffer preparation systems, chromatography columns, ultrafiltration systems, and bulk filling equipment
- Execute and review IQ/OQ/PQ protocols, including installation and operational checks, ensuring equipment performs as intended under GMP conditions
- Perform and support cleaning and sterilization validation activities, including CIP and SIP/SIPPQ qualification
- Conduct pre- and post-execution reviews of validation protocols and reports, ensuring documentation meets GMP and data integrity standards
- Support qualification of facilities and controlled environments, including cleanrooms, cold rooms, freezers, refrigerators, and biosafety cabinets (BSC)
- Act as protocol author, reviewer, and approver where applicable
- Support deviation investigations, CAPA, and change control activities related to CQV
Requirements
- Bachelor's degree in Engineering, Life Sciences, or related field
- Experience in CQV/validation within pharmaceutical or biologics manufacturing
- Strong knowledge of IQ/OQ/PQ, CIP/SIP systems, and GMP requirements
- Experience with downstream processing equipment is preferred
