Microbiology & Environmental Monitoring (EM) Supervisor
Core
Lead the site microbiology laboratory and contamination control program for sterile and non-sterile pharmaceutical manufacturing, ensuring cleanrooms and products meet cGMP, FDA, EU GMP Annex 1, and USP requirements.
Role type
Senior Microbiology & Environmental Monitoring Supervisor
Builds
Sterile and non-sterile pharmaceutical products in compliance with regulatory standards
Domain
Pharmaceutical manufacturing / Microbiology / Environmental Monitoring
Required skills
Environmental monitoring program management, Microbiology testing (bioburden, endotoxin, sterility), Root cause analysis, CAPA management, Regulatory compliance (cGMP, FDA, EU GMP), Team leadership, SOP development, Data integrity (ALCOA+)
Preferred skills
Rapid microbiological methods, MALDI-TOF identification, LIMS systems, Sterile injectables experience, Biologics or cell and gene therapy experience, Lean or Six Sigma
Technologies
LIMS, MALDI-TOF
Responsibilities
Define and maintain sampling plans for viable and non-viable monitoring, Manage utility and product microbial testing, Lead OOS/OOT investigations and CAPAs, Oversee cleanroom qualification and requalification, Train staff on aseptic behavior and gowning, Manage lab budget and staffing
Seniority
Senior, hands-on IC with people management