Sr Sterilization and Microbiology Specialist (Hybrid) US - Massachusetts

Job Title: Sterilization and Microbiology Specialist

Department: Quality and Regulatory

FLSA Status: Exempt

Position Summary:

Reports to the Sterilization & Microbiology Manager. This position is critical to supporting Insulet’s Global Sterility Assurance program. The Sterilization and Microbiology Specialist will primarily work within the Sterilization/Microbiology group for maintaining process effectiveness and providing support for new process qualification for ethylene oxide (EO) contract sterilization. This position will also support junior staff in daily microbiology laboratory functions, as applicable, including mentoring.

Responsibilities:

• Develop validation protocols/reports to fulfill international standards, industry, and corporate requirements for cleanroom qualification and microbiology lab testing.
• Perform routine assessment, qualification, and maintenance of EO sterilization processes, including obtaining accurate quotes, protocol/report generation, procuring samples needed for studies, and coordination of reference load logistics.
• Perform review of product changes or new product lines for adoption into existing sterilization, bioburden, and residual product families.
• Review of microbiology laboratory test results per documented specifications.
• Dispositioning of routine sterilization deficiencies and nonconformances for timely product release, as needed.
• Manage the qualification of laboratory equipment and test methods, as needed including drafting protocols/reports, executing or directing testing, and analyzing results per acceptance criteria.
• Lead the updating of procedures for the department, including routing in the electronic document management system.
• Lead the investigation of microbiological data deviations and excursions.
• Manage cleanroom special events, providing guidance for maintenance and engineering teams for maintaining integrity of the ISO 8 cleanroom.
• Provide guidance for Microbiology/EM personnel including training, as needed.
• Creating purchase requisitions for quotes related to sterilization and microbiology projects, as needed.
• Provide back-up for Microbiology/EM personnel, as needed, including: Perform environmental monitoring of manufacturing areas (viable air, viable surface, and non-viable particulate testing), as applicable; Manage product bioburden and bacterial endotoxin testing performed by a contract lab; Perform quality control testing of microbiological media.
• Use standard laboratory equipment including but not limited to pH meters, microplate readers, balances, incubators, chart records, autoclaves, depyrogenation ovens, microscopes, vortexers, filtration systems, particle counters, air samplers, and pipettes, as applicable.
• Support Internal quality audits, as required.
• Support site during external audits (i.e., BSI, FDA, Customer), as required.
• Performs other duties as required.

Minimum Requirements:

Education and Experience:

• Bachelors degree in microbiology, Biotechnology, or related field or equivalent experience
• A minimum of 4 years relevant experience in Microbiology laboratories and EO Sterilization.
• Prior experience working in the medical device, or similar FDA-regulated, industry is strongly preferred.
• Working knowledge of ethylene oxide (EO) sterilization per ISO 11135
• Experience with basic microbiological laboratory techniques, including aseptic technique, and environmental monitoring.
• Experience working in an ≤ISO 8 cleanroom manufacturing environment.

Preferred Skills and Competencies:

• A minimum of 4 years relevant experience each in Microbiology laboratories and EO Sterilization.
• Experience with advanced microbiological laboratory techniques, including bacterial endotoxin testing, bioburden testing and biological indicator sterility testing strongly preferred.
• Experience with qualification of EO sterilization cycles, including BI appropriateness and comparative resistance studies.
• Working knowledge of the FDA Quality System Regulation and ISO 13485 quality system standards as well as ISO 14644 series, ISO 14698 series, ISO 11737 series, ISO 11135, ISO 11138 series, and ST72.
• Must be proficient with general computer skills and Microsoft applications, specifically Word and Excel.
• Effective verbal communication and organizational skills.
• Effective technical writing capability.
• Must demonstrate great attention to detail and have ability to work efficiently.

Physical Requirements:

• International and Domestic travel may be required, up to 25%.
• Ability to lift up to 20 pounds.

NOTE: This position is eligible for hybrid working arrangements (requires on-site work from an Insulet office at least 3x/week; may work remotely other days). ## LI-Hybrid 

Additional Information:

The US base salary range for this full-time position is $108,675.00 - $163,012.50. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.