Microbiology Department Project Lead

Role: Microbiology Department Project Lead at a sterile pharmaceutical manufacturing site, serving as the technical authority for microbiology operations and compliance. Responsibilities: oversee microbiological testing, environmental monitoring, contamination control, laboratory projects, change controls, and GMP documentation; lead method validation, investigations, deviations, and CAPAs; collaborate with cross-functional teams including Quality Assurance, Manufacturing, and Regulatory Affairs; assess microbiological risks and drive continuous improvement; support inspections and audits; analyze data to identify trends and enhance product quality. Requirements: Bachelor’s in Science, Engineering, or related field; 5+ years of GMP microbiology or biologics/QMS experience; strong knowledge of cGxPs, regulatory standards, and GMP procedures; project management skills with experience leading cross-functional teams in a global environment; proficient in Office 365. Preferred: leadership in microbiology, mentoring, and strategic initiative roles. HighValue: microbiology, sterile manufacturing, GMP compliance, microbiological testing, contamination control, method validation, regulatory interactions, investigations, and continuous improvement in biologics or pharmaceutical settings. WorkSetup: not specified; likely on-site given the manufacturing environment.