Remote Microbiologist

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Microbiologist 2
Full-Time Operations Eden Prairie, MN, US

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.

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.

Review and approve microbiological data, batch records, and quality documentation.

Assist in internal and external audits, including FDA inspections and ISO 13485 audits.

Support supplier qualification and raw material microbiological risk assessments.

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., Understanding cleanroom classifications and environmental monitoring.

Travel

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.).

Onsite: Office environment with assigned workstation.

Remote positions only: Home office environment with minimum distractions.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or veteran status.

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