Expert Aseptic and Hygiene Specialist | Biologe (m/w/d)

Job Summary

This role involves acting as an Expert in Aseptics and Hygiene, primarily focusing on Quality Oversight for Aseptic Process Simulations (Media Fills) and their subsequent evaluation within a GMP-regulated pharmaceutical environment. The specialist will be responsible for drafting and maintaining critical GMP documents, including risk analyses, SOPs, and qualification documents, specifically related to cleanrooms, isolators, and pure media systems. Key daily tasks include conducting "Quality on the Floor" walk-throughs focused on hygiene and correct cleanroom behavior, serving as the Subject Matter Expert (SME) for production deviations, particularly in hygiene monitoring, and developing trending reports based on monitoring results. The ideal candidate possesses a technical or scientific background, preferably microbiology, coupled with extensive practical experience in aseptic manufacturing and familiarity with regulatory requirements like EU-GMP Annex 1 and FDA Aseptic Guide. Strong German and good English skills are essential for this position based in Pfaffenhofen, Germany.