Microbiologist 2 in Eden Prairie, Minnesota at RTI Surgical Inc
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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: https://lnkd.in/eMSfVJkM ;
RESPONSIBILITIES
- Perform microbiological testing including bioburden, endotoxin (LAL), sterility, and microbial identification
- Develop, validate, and execute test methods for raw materials, in-process samples, and finished devices
- Oversee and trend Environmental Monitoring (EM) programs (air, surfaces, personnel)
- Support aseptic processing and cleanroom operations, ensuring compliance with ISO and FDA requirements
- Investigate out-of-specification (OOS) and out-of-trend (OOT) microbiological results
- Lead contamination control strategies for collagen-based products (dermis and liquid formats)
- Review and approve microbiological data, batch records, and quality documentation
- Participate in process validation activities, including sterilization validation (e.g., gamma, EO, or filtration)
- Assist in internal and external audits, including FDA inspections and ISO 13485 audits
- Author and revise SOPs, protocols, and reports
- Train staff on microbiological practices and aseptic techniques
- Support supplier qualification and raw material microbiological risk assessments
- Other duties as assigned
REQUIREMENTS:
Education
- Bachelor's degree in Microbiology, Biology, or related field (Master’s preferred)
Experience
- 2 to 5 years of microbiology experience in medical device, pharmaceutical, or biotech industries
- Experience with bioburden and sterility testing, endotoxin testing (LAL), and microbial identification methods (e.g., Gram staining, rapid ID systems)
- Understanding cleanroom classifications and environmental monitoring.
- Experience with sterilization methods (ethylene oxide, gamma irradiation, filtration).
Certification
- N/A
Skills
- Strong attention to detail and documentation practices
- Ability to work independently in a small-company environment
- Effective communication and cross-functional collaboration
- Problem-solving and investigative mindset
- Strong knowledge of microbiological techniques and aseptic processing
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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