Microbiologist 2
About The Position
Evergen is a global industry-leading contract development and manufacturing organization (CDMO) in regenerative medicine. As the only regenerative medicine company that offers a differentiated portfolio of allograft and xenograft biomaterials at scale, Evergen is headquartered in Alachua, FL, and has manufacturing facilities in West Lafayette, IN., Eden Prairie and Glencoe, MN., Neunkirchen, DE., Glasgow, UK., and Marton, NZ. This role serves as a site SME for microbiology, sterility assurance, aseptic processing, and contamination control. The position involves implementing and continuously improving the site Contamination Control Strategy (CCS), overseeing the site environmental monitoring program, and supporting microbiological testing and method qualification. The Microbiologist 2 will review batch records, interpret microbiological data, and lead or support investigations involving microbiological OOS/OOT results, EM excursions, contamination events, and sterility failures. Additionally, the role provides microbiology support for aseptic processing, gowning qualification, sanitization/disinfection, clean utilities, validation, and qualification activities. The position also involves training and mentoring staff on microbiological techniques, aseptic behavior, contamination control, and cleanroom practices, maintaining a visible floor presence to support operations, coaching, and issue resolution. The role requires authoring, reviewing, and approving SOPs, protocols, reports, risk assessments, and related GMP documentation.
Requirements
- Bachelor’s degree in Microbiology, Biology, or related scientific discipline required.
- 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.
- 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.
Nice To Haves
- Master’s degree preferred
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.
Benefits
- Annual CIP bonus opportunity of up to $5,000.00
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
