Microbiologist 2
$70,000–$85,000 year
On-site · Eden Prairie, Minnesota, United States
Job Summary
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.
Required Qualifications
- Bachelor’s degree in Microbiology, Biology, or related scientific discipline required (Master’s degree preferred)
- 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 and knowledge of environmental monitoring methods
- Experience with cleanroom operations for aseptic manufacturing in a regulated environment
- Knowledge of ISO 13485, ISO 13408, ISO 14644, FDA Aseptic Processing Guidance, EU GMP Annex 1
- Experience with sterilization methods (EO, gamma, filtration, etc.) and related validation principles
- Strong documentation practices and cross-functional collaboration skills
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