Senior CQV Engineer
Summary
Senior engineer who commissions, qualifies, and validates cleanroom and temperature-controlled systems for pharmaceutical or biotech facilities, ensuring compliance with cGMP and regulatory standards.
Job Description
The CQV Engineer is responsible for the commissioning, qualification, and validation of CU/Cleanroom/Temperature Controlled Unit/Process systems. The role ensures that all systems are installed, tested, and qualified in compliance with cGMP, regulatory requirements, and project-specific standards.
Requirements
- Bachelors Degree in Engineering, Life Sciences, or related discipline
- 8 years experience of CQV in pharmaceutical / biotech industry.
- Strong knowledge of GMP guidelines, USP/EP, ISPE Baseline Guides, ASTM E2500, and Annex 15.
- Strong problem-solving, documentation, and stakeholder communication skills.
- Ability to work independently and as part of a cross-functional project team.
- It would be good if you know Chinese