CQV Engineer Pharmaceutical EPC
3 days ago
[Job ID: ] [Responsibilities]
- Plan, execute, and manage commissioning, qualification, and validation (CQV) activities for pharmaceutical/biotech manufacturing facilities, utilities, and process equipment.
- Develop and review CQV protocols (IQ/OQ/PQ) and reports in compliance with GMP, GAMP 5, and company procedures.
- Coordinate with engineering, project, and quality teams to ensure timely CQV execution.
- Troubleshoot and resolve CQV-related issues during project execution.
- Ensure adherence to regulatory requirements (e.g., FDA, EMA, PIC/S) and local health authority guidelines.
- Support FAT, SAT, and risk assessments for new or modified systems.
- Provide technical input during design, construction, and operational readiness stages.
- Any other ad-hoc assigned.
[Requirements]
Must
- 3 years of experience in commissioning/qualification/validation in pharmaceutical or biotech industries.
- Familiar with GMP, GAMP 5, ISPE Baseline Guides, and pharmaceutical regulations.
- Hands-on experience with utilities (e.g., WFI, clean steam, HVAC), process equipment, or cleanroom systems preferred.
- Good communication and project coordination skills.
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