CQV Engineer
About The Position
Develop, execute, and document commissioning, qualification, and validation protocols (IQ/OQ/PQ) for new and modified equipment, utilities, and facilities. Author and review qualification documents, test scripts, deviation reports, and summary reports. Perform risk-based commissioning and qualification activities in accordance with FDA, EMA, and internal quality standards. Coordinate closely with engineering, quality assurance, validation, and operations teams throughout the C&Q lifecycle. Support technology transfer, process validation, and handover to manufacturing. Participate in deviation investigations, CAPA implementation, and continuous improvement of CQV processes.
Requirements
- 3–10+ years in CQV within pharmaceutical manufacturing.
Responsibilities
- Develop, execute, and document commissioning, qualification, and validation protocols (IQ/OQ/PQ) for new and modified equipment, utilities, and facilities.
- Author and review qualification documents, test scripts, deviation reports, and summary reports.
- Perform risk-based commissioning and qualification activities in accordance with FDA, EMA, and internal quality standards.
- Coordinate closely with engineering, quality assurance, validation, and operations teams throughout the C&Q lifecycle.
- Support technology transfer, process validation, and handover to manufacturing.
- Participate in deviation investigations, CAPA implementation, and continuous improvement of CQV processes.
Benefits
- Comprehensive benefits package
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
