Microbiologist 2

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process. Microbiologist 2 Full-Time Operations Eden Prairie, MN, US 4 days ago Requisition ID: 2494 Salary Range: $70,000.00 To $85,000.00 Annually 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. 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.). Onsite: Office environment with assigned workstation. Remote positions only: Home office environment with minimum distractions. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or veteran status. #J-18808-Ljbffr