Co-op – Sterilization & Microbiology

We are looking for highly motivated, performance driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!

Position Dates: July 7, 2025- December 19, 2025

Job Title:  Co-op, Sterilization & Microbiology

Department:  Sterilization & Microbiology

Position Overview:

• Reports to the Sterilization & Microbiology Manager. This position is critical to supporting Insulet’s Global Sterility Assurance & Microbiology program. The Sterilization and Microbiology Co-op will primarily work within the Sterilization/Microbiology group managing various microbiological testing, including bioburden testing, bacterial endotoxin testing, and environmental monitoring, as applicable. This position will also support laboratory equipment qualification, maintenance, and calibration, contract sterilization qualification and routine processing, and product/process change assessments for impact on microbiological and sterilization processes.

Responsibilities:

• Support environmental monitoring of manufacturing areas (viable air, viable surface, and non-viable particulate testing), as applicable.
• Support product bioburden and bacterial endotoxin testing performed by a contract lab.
• Use standard laboratory equipment including but not limited to microplate readers, incubators, refrigerators, chart records, microscopes, vortexers, particle counters, air samplers, and pipettes, as applicable.
• Conduct quality control testing, approval, and release of microbiological media.
• Accurate completion of test records and documents for tests performed, as well as accurate computer data entry.
• Generate and revise procedures/work instructions related to microbiology and sterility assurance based on relevant state-of-the-art standards and regulatory requirements.
• Participate in microbiology laboratory investigations and support activities related to microbiology nonconformances and CAPAs.
• Support routine sterilization record review, as applicable. Support activities related to sterilization nonconformances and CAPAs, as applicable.
• Support sterilization qualifications and microbiology test method validations, as applicable.
• Support laboratory equipment qualifications, calibration, and preventive maintenance, as applicable.
• Performs other duties as required.

Education and Experience:

Minimum Requirements:

• Currently pursuing a BA/BS in Biotechnology, Biomedical Engineering, Microbiology/Biology, or related field

Preferred Skills and Competencies:   

• Completed coursework includes laboratory skills and microbiology principles.
• Experience with basic microbiological laboratory techniques, including aseptic technique.
• Knowledge of the FDA Quality System Regulation and international quality system standards as well as international standards for cleanroom controls and monitoring, microbiological test methods, ethylene oxide sterilization, and biological indicators.
• Proficiency with general computer skills and Microsoft applications, specifically Word and Excel Planning/ prioritizing.
• Technical writing capability.
• Effective verbal communication and organizational skills.
• Written and verbal communication.
• Aptitude in attention to detail, sense of urgency, and teamwork.
• Desire to learn from and share knowledge with others.

Physical Requirements (if applicable):

• Ability to lift up to 30 lbs.
• Bending, reaching, etc.
• Typical office conditions, i.e., sitting/standing at desk, extensive computer use, etc.
• Navigating large facility (travelling between office area and cleanroom or laboratory areas multiple times per day).
• Ability to enter cleanroom and wear cleanroom clothing, i.e., removing jewelry, wearing a smock over clothes, applying shoe covers, wearing head/face covering.

NOTE: This position requires on-site working (requires on-site office/plant/lab work). #LI-Onsite