Quality Control Microbiology Specialist

Egenesisbio; Madison (WI); On-site; USD 60,000 - 90,000; Full time

Job summary

eGenesis in the Greater Madison Area, Wisconsin, seeks a QC Microbiology Specialist to lead the environmental monitoring program, perform sampling, testing, and reporting, and ensure compliance with cGMP in our manufacturing facilities in Wisconsin and Indiana.

The role requires hands-on expertise in microbiology, aseptic technique, and regulatory knowledge, with about 20% travel. You will collaborate across QA, manufacturing, and QC teams to drive contamination control and data trending.

Qualifications

• Proficient in microbiology methods and aseptic technique for EM in GMP environments.
• Strong understanding of US and EU cGMP regulations/guidance.
• Able to manage multiple projects, priorities, and timelines.

Responsibilities

• Coordinate the environmental monitoring program across GMP facilities, ensuring proper sample collection, transport, and processing.
• Manage schedules for routine and non-routine monitoring with internal teams and contract labs.
• Perform EM sample collection and provide guidance and training to team members.
• Maintain complete documentation in electronic test methods.
• Review and trend EM data and support deviations with corrective actions.
• Prepare data, SOPs, COAs, protocols, and reports for QA review.
• Collaborate with QC contamination control and support cleaning and gowning programs.
• Travel ~20% between Wisconsin and Indiana; primary location in Wisconsin.

Skills

Microbiology methods

Aseptic technique

Regulatory compliance

Project leadership

Communication skills

Education

B.S./M.S. in Life Sciences or related field

Job description

About eGenesis

eGenesis is a clinical‑stage biotechnology company developing human‑compatible engineered organs to address the severe global organ shortage. The Company’s proprietary genome engineering platform enables extensive, multiplex gene edits to remove key biological barriers, add protective human transgenes, and inactivate endogenous retroviruses. EGEN‑2784, genetically engineered porcine kidney, is the Company’s lead program and is currently being evaluated in a multi‑patient Expanded Access study at MGH. eGenesis is headquartered in Cambridge, MA.

Position Summary

eGenesis is seeking an innovative QC Microbiology Specialist to lead and provide the technical and strategic oversight of eGenesis’s environmental monitoring program. In this position you will be responsible for hands‑on environmental monitoring sampling, testing, reporting and trending of eGenesis GMP manufacturing facilities in Rensselaer, IN. You will ensure activities are executed in a cGMP compliant manner and have the opportunity to work collaboratively on implementation and maintenance of our contamination control program. The ideal candidate will be independently motivated, a strong communicator and demonstrate proficiency in regulatory compliance. This position will be in the Greater Madison Area in Wisconsin.

Responsibilities

• Coordinate the environmental monitoring (EM) program at both eGenesis manufacturing facilities ensuring the collection, transport and processing of air and surface samples.
• Manage the schedule for all routine and non‑routine monitoring activities internally and with external contract laboratory.
• Perform environmental monitoring sample collection (nonviable, viable, and surface) as well as providing guidance and training on procedures to additional team members.
• Keep complete and accurate documentation in electronic test methods.
• Review and trend environmental monitoring data.
• Support EM and laboratory deviations. Identify and implement corrective actions to prevent reoccurrence.
• Author, review, and/or approve data, SOPs, COAs, protocols, reports, deviations, and other quality records.
• Work collaboratively with QC contamination control representative and work cross functionally to maintain and enhance cleaning/disinfection program, material/equipment and gowning programs as applicable.
• Travel (~20% of time) between manufacturing sites in Wisconsin and Indiana; primary location will be in Wisconsin.

Qualifications

• B.S./M.S. in Life Sciences or related field with 0‑3 years of experience, in GMP QC Laboratory.
• Proficient in microbiology methods (plate enumeration, growth promotion, microbial ID, etc.) and aseptic technique needed to perform EM in a GMP environment.
• Strong knowledge of US and EU cGMP regulations/guidance.
• The ability to work and lead in a fast‑paced environment, manage priorities, and maintain timelines for multiple projects is essential.
• Effective communication skills, both verbal and written, at all levels and across various functions.