Validation Expert/Engineer for Active Ingredient Production | Validierungsexperte/-ingenieur (m/w/d) für die Wirkstoffproduktion

Job Summary

This role involves the preparation, coordination, and execution of qualification and validation activities within the production of biological and biotechnological active ingredients, ensuring strict adherence to Good Manufacturing Practice (GMP) standards. Key responsibilities include creating risk analyses, developing qualification/validation plans and reports, managing calibration protocols, and coordinating process validations and cleaning monitoring. The expert will also handle Change Control and CAPA processes, support GMP inspections and customer audits, and establish internal quality standards. The ideal candidate holds a degree in a natural science or technical field (e.g., Biotechnology or Process Engineering) and ideally possesses professional experience in validation within a GMP environment. This position offers significant autonomy, flexible working hours, and the chance to contribute to a leading, innovative pharmaceutical manufacturer in Germany.