Microbiologist 2

Evergen•Eden Prairie, MN

1d•Onsite

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 is located in Eden Prairie, MN and has an annual CIP bonus opportunity of up to $5,000.00.

Requirements

Bachelor's degree in Microbiology, Biology, or related field (Master’s preferred)
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).
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

Nice To Haves

Master’s degree

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