Validation Expert, Aseptic Process Validation | Validation Expert (m/w/d) Aseptische Prozessvalidierung – Biopharma / Quality / GMP

Job Summary

This role involves critical planning, coordination, and execution of validation activities for aseptic processes, primarily focusing on Media Fills, microbiological shelf life studies, and personnel qualifications within the biopharmaceutical sector. The expert will be instrumental in generating and maintaining comprehensive validation documentation, including Master Validation Plans, protocols, reports, risk assessments, and managing deviations and Change Controls. A key responsibility is representing specialized validation topics in interdisciplinary project teams, during internal and external audits, and regulatory inspections. Candidates must possess a Master's degree in a natural science or technical field, or a Bachelor's degree coupled with extensive professional experience in the pharmaceutical or biopharmaceutical industry. Success requires in-depth knowledge of GMP and regulatory requirements, alongside conversational fluency in English, to ensure compliance with internal, global, and statutory guidelines.