Aseptic Microbiology Specialist, Environmental Monitoring & Sterility Assurance
About The Position
Step into a night where precision protects patients As an Aseptic Microbiology Specialist, you will be the steady hand behind our sterility assurance program. Your work safeguards in‑process and finished products, as well as raw materials, through rigorous microbiological testing. You’ll operate within USP, ISO, and GMP frameworks and follow local and global SOPs, product test procedures, and safety requirements. A night in the life You arrive prepared to don proper gowning and begin environmental and personnel monitoring that keeps manufacturing running safely: Conduct routine environmental monitoring rounds: surface sampling, employee gowning assessments, viable air sampling, and total airborne particle counts. Set up and maintain the lab: prepare culture media and supplies, operate the autoclave for sterilization, and keep microbiology inventory current. Perform growth promotion testing and sterility verification to confirm media performance. Execute water, disinfectant, and pre-sterilized product testing using aseptic technique within a laminar flow hood. Read plates and liquid media, capture final results, and document meticulously using good documentation practices. Run particulate matter testing for finished product inside a laminar flow hood and record accurate data. Support validation and production by testing biological indicators aseptically. Load sterility isolators with required materials and samples, run the VHP cycle, and carry out sterility testing of finished product within the isolator. Receive and log consumables, media, and other supplies to maintain readiness. Review microbiology data promptly for procedural compliance, accuracy, and adherence to GDP. Quality and compliance Your work aligns to local and global SOPs, product test procedures, safety protocols, USP, ISO, GMP, and applicable governmental regulations.
Requirements
- Bachelor’s degree in Biology, Microbiology, or related life science.
- Fluency with metric conversions and ratios; proficiency with Excel, Word, and customized systems.
- Working knowledge of cGMP and good documentation practices; strong technical/scientific writing.
- Skill with laminar flow hoods and isolators; consistent application of aseptic technique.
Nice To Haves
- Background in aseptic manufacturing operations and aseptic laboratory practices (highly preferred).
Responsibilities
- Conduct routine environmental monitoring rounds: surface sampling, employee gowning assessments, viable air sampling, and total airborne particle counts.
- Set up and maintain the lab: prepare culture media and supplies, operate the autoclave for sterilization, and keep microbiology inventory current.
- Perform growth promotion testing and sterility verification to confirm media performance.
- Execute water, disinfectant, and pre-sterilized product testing using aseptic technique within a laminar flow hood.
- Read plates and liquid media, capture final results, and document meticulously using good documentation practices.
- Run particulate matter testing for finished product inside a laminar flow hood and record accurate data.
- Support validation and production by testing biological indicators aseptically.
- Load sterility isolators with required materials and samples, run the VHP cycle, and carry out sterility testing of finished product within the isolator.
- Receive and log consumables, media, and other supplies to maintain readiness.
- Review microbiology data promptly for procedural compliance, accuracy, and adherence to GDP.
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What This Job Offers
Job Type
Full-time
Number of Employees
5,001-10,000 employees
