Aseptic and Hygiene Monitoring Specialist | Laborfachkraft (m/w/d) Aseptik- und Hygienemonitoring

Job Summary

This role seeks an Aseptic and Hygiene Monitoring Specialist to ensure stringent quality oversight within the production of innovative pharmaceuticals at a major company based near Munich. The core responsibility involves implementing and documenting Quality Oversight during Aseptic Process Simulations (Media Fills) and conducting regular Quality-on-the-Floor rounds focused on hygiene and cleanroom behavior. You will be instrumental in evaluating and trending hygiene monitoring results from cleanrooms and isolators, creating detailed reports, and acting as a Subject Matter Expert (SME) to production teams regarding deviations and media fill planning. Furthermore, you will be responsible for training employees on hygiene, aseptic techniques, and cleanroom conduct. Success requires extensive practical experience in aseptic manufacturing or Quality Assurance within a GMP-regulated setting, coupled with a technical or scientific background, ideally in microbiology. Expertise in regulatory frameworks like EG-GMP Annex 1 and the FDA Aseptic Guide is mandatory, ensuring the highest standards of quality control are maintained.