Site Microbiologist (m/w/d)
Core
Applies advanced GMP microbiology expertise to QC Microbiology Lab, sterile manufacturing areas, and utility systems, ensuring supply of medicines in Germany, Europe, and worldwide.
Role type
Senior Responsible Scientist (Site Microbiologist)
Builds
Sterile injectable drug production capabilities and quality assurance for global supply
Domain
Pharmaceutical manufacturing / GMP Quality Control
Required skills
GMP microbiology expertise, method validation, water systems management, environmental monitoring, sterilization/depyrogenation equipment knowledge, cleaning validation, audit response, root cause analysis, technical training
Preferred skills
Rapid microbial methods, analytical instrument validation lifecycle, contamination control strategy (CCS), regulatory compliance (EU GMP Annex 1)
Technologies
Autoclaves, isolators, dry heat tunnels, CIP/SIP processes, bioburden/endotoxin/sterility testing equipment
Responsibilities
Provide expert oversight of method transfers and validations within QC Microbiology Laboratory; Act as microbiological SME for water systems (WFI, PW, clean steam); Act as microbiological SME for environmental monitoring in Grade A to D areas; Understand and interpret results from sterilization/depyrogenation equipment and cleaning validation; Act as front-room SME discussing topics with regulatory bodies and during audit tours; Lead GMP investigations including OOS/OOT and deviations; Perform technical review and release of raw material, in-process, and finished product data; Provide technical training and mentor analysts
Seniority
Senior, hands-on IC