- Kiel, Schleswig-Holstein, Germany
- Senior
- 8+ years
Senior CQV Engineer leading validation lifecycle activities for bioprocessing equipment and facility systems in a manufacturing environment.
Responsibilities
- Author, review, and execute key validation deliverables (VMPs, URS, DQ, FAT/SAT, IQ/OQ/PQ) using ISPE risk-based verification approaches in full compliance with EU GMP
- Serve as the on-site technical SME during internal quality audits and external regulatory agency inspections
- Lead the qualification and validation of critical upstream and downstream bioprocessing equipment, facility systems, and CIP/SIP cycles
- Oversee CQV and monitoring for critical utility systems (WFI, PW, Clean Steam, Process Gases) and lead technical root-cause investigations
- Direct cleanroom classification and airflow smoke studies, and manage large-scale thermal mapping for cold rooms, freezers, incubators, and warehouses
Requirements
- Bachelor’s degree in engineering, life sciences, or a related technical discipline
- Nice to have: strong command of risk-based verification approaches
- Nice to have: hands-on qualification experience with bioreactors, fermenters, single-use technologies, and autoclaves
- Nice to have: proven diagnostic and root-cause troubleshooting capability
- Nice to have: proficiency in environmental tracking and thermal validation hardware/software