Sterility Assurance Engineer 2

Job Description

Job Description

Location: Eden Prairie, MN

Annual CIP bonus opportunity of up to $5,000.00

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.

Read more about this change and Evergen’s commitment to advancing regenerative medicine here:

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.
• 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.
• Reviews validations and risk management activities to support regulatory submissions, sustaining activities, and product launches are on time and have a high level of customer and patient focus
• Leads and conducts problem solving through change management, nonconformance workflows, and continuous improvement or new product development initiatives
• Reviews and edits nonconformance/CAPA investigation and disposition phases for team members and assists in the preparation and presentation of materials for quality initiatives
• Strong understanding of microbiology principles related to facility environmental control, environmental monitoring, cleaning, and sterilization – gamma irradiation.
• Experience with or overseeing validation and qualification of facilities, processes, equipment, and systems related to sterility assurance, including aseptic processing.
• Other duties as assigned

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 11137), 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.
• 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, and celebrated.

At Evergen, we are committed to fostering an inclusive workplace where we embrace the richness of our diversity and ensure that every voice is heard, respected, and celebrated. We believe that by embracing diversity and promoting inclusivity, we not only uphold our values but also strengthen our position as the CDMO of Choice in regenerative medicine solutions. We recognize that cultivating a growth mindset is essential to our success, and we are dedicated to continuous learning and improvement in our diversity, equity, and inclusion efforts. Through accountability and action, we strive to create an environment where individuals can thrive, innovate, and contribute their unique perspectives to drive our collective success.

Montagu Private Equity (“Montagu”), a leading European private equity firm, acquired Evergen in 2020 and has supported the transformation of the company to its next level of potential.

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