Hiring: Staff Sterilization Specialist (Hybrid, Acton MA) Company: Insulet Corporation Location: Massachusetts, United States Job Posted Time: 2026-09-10 10:27:06 Employment Type: Contract / Hybrid Target Skills & Keywords : R, Regulatory Compliance About the job Required Skills: •Technical Leadership & Subject Matter Expertise •Serve as the primary scientific authority for EO sterilization processes, including cycle development, optimization, and validation. •Provide expert guidance on alternate sterilization modalities (e.g., radiation, VHP, and other emerging technologies, etc.) including feasibility, compatibility, and risk assessments. •Act as the escalation point for complex sterilization deviations, investigations, and root cause analyses, ensuring scientifically sound and compliant outcomes. •Provide technical leadership for EO residuals for compliance with global regulatory requirements. •Lead initiatives to optimize sterilization cycles, reduce product residual levels, increase throughput, and improve overall process robustness without increasing compliance risk. •Evaluate and support novel technologies, process improvements, and sustainability initiatives related to sterilization. •Partner with Manufacturing and Supply Chain to proactively identify and mitigate sterilization-related risks associated with scaling, site changes, and/or complex product/packaging changes. Qualifications: •Bachelor’s degree in Microbiology, Chemical Engineering, Biomedical Engineering, Materials Science, or a related scientific discipline. •5+ direct experience with EO sterilization in a regulated medical device or pharmaceutical environment. •Deep working knowledge of sterilization validations, requalifications, residuals, and deviation management. •In-depth knowledge of global regulatory and quality system requirements related to sterilization and microbiological control. •Demonstrated ability to independently lead complex technical initiatives. •Prior participation in regulatory inspections, technical audits, or standards committees. •Proven ability to translate complex scientific concepts into clear, actionable guidance for technical and non-technical audiences. •Scientific rigor and sound technical judgment •Strong problem-solving and analytical skills •Strong collaboration skills, enabling effective cross‑functional teamwork and aligned goal delivery Compensation: •$130,400 - $195,650 / year •Competitive benefits and rewards package •Medical, dental, and vision insurance Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!