Quality Control Microbiology Technician

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 Technician 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 Northwest, 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. 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 Northwest, 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