Job Responsibilities
- Plan and execute commissioning, qualification, and validation (CQV) for facilities, utilities, and process equipment.
- Develop, review, and complete CQV protocols and reports (IQ/OQ/PQ) in compliance with GMP and GAMP 5.
- Coordinate with engineering, quality, and project teams to ensure timely CQV delivery and regulatory compliance.
- Troubleshoot and resolve CQV-related issues, support FAT/SAT, risk assessments, and operational readiness.
- Ensure adherence to FDA, EMA, PIC/S, and local health authority guidelines.
Job Requirements
- Min Degree in Engineering, Life Sciences, or its equivalent.
- At least 2 years of CQV experience in pharmaceutical/biotech industries
- Strong knowledge of GMP, GAMP 5, ISPE Baseline Guides, and pharmaceutical regulations.
- Hands-on experience with utilities (WFI, clean steam, HVAC), process equipment, or cleanroom systems preferred.
Interested candidates who wish to apply for the advertised position, please click APPLY to submit your application or send in your resume to [Confidential Information]
EA License No: 13C6305
Reg. No.: R1874608 (Lee Jia Hou)
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