We are seeking a CQV Lead to oversee commissioning, qualification, and validation (CQV) for clean utilities and process systems in a USP & DSP environment. The role ensures compliance with GMP, FDA, and EMA regulations while driving efficiency and quality improvements.
Key Responsibilities:
- Lead CQV activities for clean utilities (WFI, PW, Clean Steam) and process systems.
- Develop and execute VMPs, risk assessments, and IQ/OQ/PQ protocols.
- Oversee FAT, SAT, troubleshooting, and validation execution.
- Collaborate with cross-functional teams to ensure regulatory compliance.
- Provide leadership, mentorship, and technical expertise to CQV teams.
Requirements:
- 5+ years’ CQV experience in biopharma (USP & DSP).
- Strong knowledge of GMP, FDA, EMA regulations.
- Expertise in validation lifecycle and risk-based approaches.
- Degree in Engineering or Science (Chemical, Mechanical, Biotech, etc.).
- Excellent leadership, problem-solving, and communication skills.
Darwin Recruitment AG is a Zurich based, SECO licensed, privately owned subsidiary of Darwin Professional Staffing Group Ltd (a Global IT Recruitment Consultancy).
Darwin Recruitment AG manages client relationships whilst also utilising Darwin Professional Staffing Group databases and networks to source Candidates and fulfil client requests.
We do not ask for a placement fee from Candidates/Employees.
If you wish to contact a specialist regarding this role, or your job search in general, please contact +41 (0)43 456 29 09
Greg King