Microbiologist

JOB SUMMARY: Perform microbiological testing, environmental monitoring, water sampling and analysis, culture media preparation, and microorganism identification to ensure compliance with cGMP, pharmacopeial standards, and pharmaceutical quality requirements. KEY RESPONSIBILITIES: • Conduct environmental monitoring, including air and surface sampling, and perform trend analysis. • Perform microbiological testing of Purified Water (PW), Water for Injection (WFI), and other utility systems. • Prepare, sterilize, and perform growth promotion testing of microbiological culture media. • Conduct microbial limit, bioburden, bacterial endotoxin, and specified microorganism testing for raw materials, packaging materials, in-process samples, and finished products. • Perform disinfectant preparation, compressed air and gas testing, and other assigned laboratory analyses. • Investigate OOS/OOT results and environmental excursions, supporting CAPA activities. • Maintain laboratory equipment, documentation, and data integrity in accordance with GMP and ALCOA+ requirements. QUALIFICATIONS: • Bachelor’s degree in microbiology, Biology, or a related scientific field. • Knowledge of pharmaceutical microbiology, manufacturing processes, and cGMP requirements is preferred. • Strong communication, analytical, and interpersonal skills. • Ability to work effectively in a cross-functional environment. Show more Show less

Environmental monitoring (air and surface sampling), microbiological testing of Purified Water (PW) and Water for Injection (WFI) and other utilities, preparation/sterilization and growth promotion testing of microbiological culture media, microbial limit, bioburden, bacterial endotoxin, and specified microorganism testing for raw materials, packaging materials, in-process samples, and finished products; disinfectant preparation, compressed air and gas testing; investigate OOS/OOT results and environmental excursions; support CAPA activities; maintain laboratory equipment, documentation, and data integrity in accordance with GMP and ALCOA+ requirements.