Site Microbiologist (m/w/d)
Core
Applies advanced GMP microbiology expertise to QC Microbiology Lab, sterile manufacturing areas, and utility systems to ensure medicine supply and compliance.
Role type
Senior Responsible Scientist (Site Microbiologist)
Builds
Sterile injectable drugs for Germany, Europe, and worldwide
Domain
Pharmaceutical manufacturing / GMP Quality Control
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (GMP compliance, sterile manufacturing support)
Required skills
GMP microbiology expertise, method validation, water systems management, environmental monitoring, sterilization/depyrogenation equipment knowledge, cleaning validation, root cause analysis, regulatory audit support, technical training
Preferred skills
Rapid microbial methods knowledge, analytical instrument validation lifecycle expertise, contamination control strategy (CCS) understanding
Technologies
Autoclaves, isolators, dry heat tunnels, CIP/SIP processes, analytical instruments for sterility/bioburden/endotoxin testing
Responsibilities
Provide expert oversight of method transfers and validations in QC Microbiology Lab; Act as microbiological SME for water systems (WFI, PW, clean steam); Act as microbiological SME for environmental monitoring in Grade A-D areas; Understand and interpret results from sterilization/depyrogenation equipment and cleaning validation; Act as front-room SME during regulatory audits; Lead GMP investigations (OOS/OOT, deviations) using root cause analysis; 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 with extensive experience