Microbiologist 2

Responsibilities

• Serve as a site SME for microbiology, sterility assurance, aseptic processing, and contamination control.
• Implement and continuously improve the site Contamination Control Strategy (CCS).
• Oversee the site environmental monitoring program, including trending, response procedures, and investigation triggers.
• Support microbiological testing and method qualification including bioburden, endotoxin, sterility, and microbial characterization.
• Review batch records, interpret microbiological data, trends, and other quality documentation to assess compliance and product impact.
• Lead or support investigations involving microbiological OOS/OOT results, EM excursions, contamination events, and sterility failures.
• Provide microbiology support for aseptic processing, gowning qualification, sanitization/disinfection, clean utilities, validation, and qualification activities.
• Train and mentor staff on microbiological techniques, aseptic behavior, contamination control, and cleanroom practices.
• Maintain a visible floor presence to support operations, coaching, and issue resolution.
• Author, review, and approve SOPs, protocols, reports, risk assessments, and related GMP documentation.

Qualifications

• Education: Bachelor’s degree in Microbiology, Biology, or related scientific discipline required. Master’s degree preferred.
• Experience: Minimum 4 years of relevant experience in microbiology, sterility assurance, contamination control, or aseptic processing in a regulated GMP environment. Strong hands-on microbiology expertise required, including direct experience with microbiological testing methods and laboratory practices, and environmental monitoring methods. Experience with cleanroom operations for aseptic manufacturing in a regulated environment. Strong working knowledge of ISO 13485, ISO 13408, ISO 14644, FDA Aseptic Processing Guidance, EU GMP Annex 1. Experience with collagen-based product manufacturing in pharmaceutical, biopharmaceutical, biotechnology, or medical device industries. Strong knowledge of sterilization methods such as ethylene oxide (ISO 11135), gamma irradiation (ISO 11131), filtration (ISO 13408-2), and liquid chemical sterilant (ISO 14160) modalities.

Skills

• Strong attention to detail and documentation practices.
• Strong hands-on knowledge of bioburden, sterility, endotoxin, microbial identification, and environmental monitoring.
• Understanding of cleanroom classifications, aseptic gowning, contamination control, and EM systems.
• Familiarity with sterilization methods and validation principles, including filtration, EO, gamma irradiation, and related approaches as applicable.
• Strong analytical, investigation, root cause analysis, and technical writing skills.
• Ability to work independently, manage multiple priorities, and make sound risk-based decisions.
• Strong communication and cross-functional collaboration skills.