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CQV Specialist Role
3 weeks ago
We are seeking an experienced CQV professional to support a high-impact capital project in a drug substance manufacturing environment.
Key Responsibilities:- Develop and implement full-cycle CQV documentation, including URS, DQ, FAT/SAT, IQ, OQ, and support PQ activities where required
- Commission equipment and systems, verifying installation, utility integration, control functionality, and safety features
- Lead CQV activities across systems, including bioreactors and single-use technologies, chromatography columns, CIP and SIP systems, WFI, clean steam, and process gases, process tanks, skids, and associated piping
- Conduct impact assessments and risk assessments, and define qualification strategies
- Collaborate with vendors, automation, engineering, and quality teams to coordinate execution and resolve issues
- Maintain GMP-compliant documentation with attention to data integrity
- Bachelor's degree in Engineering, Life Sciences, or a related field
- Minimum 5 years of CQV experience in drug substance or biologics manufacturing under GMP
- Hands-on experience with commissioning and qualification of large-scale bioprocess equipment, utility systems, automation-integrated systems
- Strong knowledge of CQV best practices and industry standards