eGenesis, Inc.
Quality Control Microbiology Technician
eGenesis, Inc., Wawasee Village, Indiana, United States
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
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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
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