The CQV Engineer is responsible for supporting commissioning and qualification activities for pharmaceutical or biotechnology manufacturing facilities, equipment, utilities, and systems. The role ensures systems are properly commissioned, qualified, documented, and compliant with
GMP, FDA, GAMP
5, and applicable regulatory requirements.
Key Responsibilities:
Develop and execute Commissioning and Qualification (C&Q) documentation and activities. Prepare and execute URS, DQ, IQ, OQ, and PQ protocols. Support equipment, facility, utility, and process qualification. Review engineering/design documentation, specifications, and P&IDs. Develop and execute FAT/SAT activities with vendors and project teams. Perform field verification, commissioning, and qualification testing. Document test results, discrepancies, deviations, and corrective actions. Support risk assessments and qualification strategy development. Work with Engineering, Quality, Manufacturing, Automation, and Validation teams. Support deviation investigations, CAPA, and change control activities. Ensure qualification activities comply with
GMP, FDA, GAMP
5, and company procedures. Coordinate with vendors and contractors during equipment installation, startup, and qualification. Prepare final qualification reports and support system release.
Requirements:
Bachelor's degree in Engineering, Life Sciences, or related technical field. Typically 3 7+ years of CQV/Validation experience in pharmaceutical, biotechnology, or regulated manufacturing. Experience with
IQ/OQ/PQ, FAT/SAT, URS, DQ.
Strong GMP and regulatory knowledge. Experience with manufacturing equipment, utilities, facilities, or process systems. Knowledge of
GAMP 5, FDA, 21 CFR
Part 11 and data integrity principles. Experience with deviations, CAPA, change control, and risk assessments. Strong technical writing and documentation skills. Ability to work independently and collaborate with cross-functional teams.
