Quality Control Microbiology Technician

eGenesis, Inc.; Wawasee Village (IN); On-site; USD 60,000 - 80,000; Full time

Job summary

A biotechnology company in Wawasee Village, IN is seeking a QC Microbiology Specialist to manage environmental monitoring and ensure compliance with cGMP regulations. This role will involve hands-on sampling, testing, and documentation while collaborating with team members on contamination controls. Ideal candidates should possess a B.S./M.S. in Life Sciences and have a strong foundation in microbiology, regulatory compliance, and effective communication skills. Flexibility for travel between sites is required.

Qualifications

• 0-3 years of experience in GMP QC Laboratory.
• Strong knowledge of US and EU cGMP regulations and guidance.
• Ability to work and lead in a fast-paced environment.

Responsibilities

• Coordinate the environmental monitoring program at manufacturing facilities.
• Perform sample collection and provide training to team members.
• Review and trend environmental monitoring data.
• Work collaboratively on contamination control programs.

Skills

Microbiology methods

Aseptic technique

Effective communication

Ability to manage priorities

Education

B.S./M.S. in Life Sciences

Job description

Company Mission

eGenesis is dedicated to giving patients with organ failure a second chance at life by harnessing the power of genome engineering to create safe, effective, and readily available solutions.

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 Rensselaer, IN.

Primary Responsibilities

• Coordinate the environmental monitoring (EM) program at both eGenesis manufacturing facilities ensuring the collection, transport and processing of air, surface and personnel 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, surface and personnel) 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, analytical methods, 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
• This position will require some travel (20% of time) between manufacturing sites, but primary location will be Rensselaer, IN

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