
CQV Engineer Pharmaceutical EPC
19 hours 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.
We regret that only shortlisted candidates will be notified. However, rest assured that all applications will be updated to our resume bank for future opportunities.
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EA License no.: 07C5771
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EA Personnel Name: Ayumu Matsuki
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