Validation Expert | Validation Expert (m|w|d)

Job Summary

This role involves planning, coordinating, and documenting validation activities for sterile and biotechnological manufacturing processes in a modern production facility being established in Cologne Mülheim. The Validation Expert will focus on processes including media fills, cleaning validation, sterilization, upstream/downstream processing, and aseptic filling of medical devices. A critical part of the job is ensuring strict adherence to relevant regulatory requirements, including GMP, ISO 13485, and ICH guidelines, and supporting audits and inspections by reviewing and preparing qualification documents. The ideal candidate possesses a degree in natural sciences or engineering, several years of relevant professional experience, and fluent German and good English skills. This is an exciting opportunity to help build and shape a new operational site focused on high-quality clinical reagents for cutting-edge biomedical research and cell/gene therapies.