Sterility Assurance Microbiologist

Microbiology Site SME

Location:

Eden Prairie, MN

Annual CIP bonus opportunity of up to $5,000.00

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.

Travel:

• N/A

Safety:

• Physical Requirement:
• Move or lift objects up to 25 pounds
• Frequent (>75%) stationary position (standing or sitting) while utilizing digital displays
• Frequent (>75% fine manipulation using hands and fingers (typing, opening, writing, clicking, paper sorting, etc.)
• Working Environment:
• Onsite:
  Office environment with assigned workstation
• Remote positions only:
  Home office environment with minimum distractions

More about Evergen:

Evergen provides customers across a diverse set of market segments with leading-edge expertise, scale, and flexibility across end-to-end services including design, development, regulatory support, verification and validation, manufacturing, and supply chain management.

Evergen is rooted in a steadfast commitment to quality, integrity, and patient safety with a focus on five key values:

• Accountable: We own our actions and decisions.
• Agile: We embrace change to stay ahead of the curve and evolve to drive innovation and growth.
• Growth Mindset: We embrace challenges as opportunities for continuous learning.
• Customer-Centric: We prioritize customers at every touch point.
• Inclusive: We thrive on the richness of our diversity and ensure every voice is heard, respected,…