Co-op, Sterilization and Microbiology: January - June 2027 (Onsite)

Position Summary

Insulet Corporation is seeking a proactive and detail-oriented Sterilization & Microbiology Co-op to support Insulet's Global Sterility Assurance program. The Sterilization and Microbiology Co-op will primarily work within the Sterilization & Microbiology group support laboratory equipment maintenance/calibration, microbiology test program management (environmental monitoring, bacterial endotoxin testing, and product bioburden), and maintaining process effectiveness for ethylene oxide (EO) sterilization.

Responsibilities

• Support environmental monitoring program for controlled manufacturing areas (viable air, viable surface, and non-viable particulate testing), as applicable.
• Support management of product bioburden and bacterial endotoxin testing performed by contract labs.
• Support quality control testing, approval, and release of microbiological media.
• Use standard laboratory equipment including but not limited to microplate readers, incubators, chart records, microscopes, vortexers, particle counters, air samplers, and pipettes, as applicable.
• Accurate completion of test records and documents for tests performed, as well as accurate computer data entry.
• Support generation and revision of procedures/work instructions related to microbiology & sterility assurance.
• Support microbiology laboratory investigations. Support activities related to microbiology nonconformances and CAPAs.
• Support activities related to sterilization nonconformances and CAPAs, as applicable.
• Support sterilization requalifications and microbiology test method validations, as applicable.
• Support laboratory equipment qualifications, calibration, and preventive maintenance (as applicable).
• Participate in developmental and departmental training.
• Support internal and external quality audits, as required.
• Performs other duties as required.

Minimum Requirements

Education and Experience:

• Currently pursuing a Bachelor's degree in Microbiology, Biotechnology, Biology, Pharmaceutical Sciences, or a related field.

Preferred Skills and Competencies

• Strong organizational skills and attention to detail.
• Effective verbal communication.
• Effective technical writing capability.
• Experience with aseptic technique.
• Interest in Ethylene Oxide sterilization is strongly preferred.
• Ability to handle confidential information with discretion.
• Able to work effectively in a team environment.
• Previous co-op experience is a plus.

Physical Requirements

• Ability to lift up to 20 pounds.
• Ability to wear gowning materials in a controlled manufacturing environment.