Aseptic and Hygiene Expert | Experte (m/w/d)Aseptik und Hygiene

Job Summary

This critical role supports quality assurance by overseeing and managing aseptic manufacturing processes within a highly regulated environment. Key responsibilities include conducting Quality Oversight for Aseptic Process Simulations (Media Fills), evaluating results, and generating comprehensive reports. The expert will perform regular Quality-on-the-Floor inspections focusing on hygiene, aseptics, and cleanroom behavior, ensuring meticulous documentation of all findings. Furthermore, the role involves acting as a Subject Matter Expert (SME) for production, providing specialized support during deviations related to hygiene monitoring, and evaluating trend reports for cleanroom and isolator monitoring results. The ideal candidate possesses several years of practical experience in aseptic manufacturing, deep knowledge of regulatory standards like EU-GMP Annex 1 and FDA Aseptic Guide, and a completed scientific or technical education, ideally with a microbiological focus. This is a permanent position offering the opportunity to ensure the highest standards of quality and compliance through specialized expertise and staff training.