Staff Sterilization Specialist

Insulet Corporation

Sterilization expert optimizing EO processes for Insulet’s diabetes medical devices. Leading validation, residual, compliance, and scalability initiatives across product and manufacturing operations.

Posted 8/5/2026full-timeActon • Massachusetts • 🇺🇸 United StatesLead💰 $130,400 - $195,650 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in EO Sterilization Cycle Development, Optimization, and Validation, with a strong understanding of global regulatory standards and quality systems. Capable of leading complex technical initiatives and translating scientific concepts into actionable guidance for diverse audiences.

Highest-signal resume keywords

EO Sterilization ExpertiseSterilization ValidationRegulatory ComplianceTechnical LeadershipProblem-Solving Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Sterilization Cycle OptimizationRisk AssessmentTechnical Report WritingMicrobiological ControlProcess Improvement

Soft Skills

Collaboration SkillsClear Technical CommunicationMentoring

Tools & Technologies

ISO 11135ISO 11138 SeriesISO 11737ISO 10993-7ISO 14937

Industry Keywords

Medical DevicePharmaceuticalRegulatory InspectionsQuality System RequirementsEmerging Sterilization Technologies

About the role

Key responsibilities & impact

Provide scientific leadership and decision-making for global sterilization processes.
Serve as the primary scientific authority for ethylene oxide (EO) sterilization cycle development, optimization, and validation.
Provide expert guidance on radiation, VHP, and emerging sterilization modalities, including feasibility, compatibility, and risk assessments.
Escalate and lead complex sterilization deviations, investigations, and root cause analyses.
Lead initiatives to optimize sterilization cycles, reduce residual levels, increase throughput, and improve process robustness.
Evaluate novel technologies, process improvements, and sustainability initiatives.
Partner with Manufacturing and Supply Chain to identify and mitigate sterilization-related risks associated with scaling, site changes, and product or packaging changes.
Provide sterilization design input for new products, packaging, materials, and manufacturing processes.
Lead or support sterilization impact assessments for product, process, and supplier changes.
Define testing strategies and acceptance criteria for product adoption.
Ensure compliance with global sterilization standards and regulations.
Support internal and external audits and inspections as a technical subject matter expert.
Monitor regulatory and industry-standard changes and translate them into implementation strategies.
Develop and deliver technical training, guidance, and mentoring.
Author, review, and approve protocols, reports, risk assessments, and technical justifications.
Represent the company on relevant industry committees and working groups.

Requirements

What you’ll need

Bachelor’s degree in Microbiology, Chemical Engineering, Biomedical Engineering, Materials Science, or a related scientific discipline.
5+ years of direct experience with EO sterilization in a regulated medical device or pharmaceutical environment.
Deep working knowledge of sterilization validations, requalifications, residuals, and deviation management.
Strong understanding of global regulatory and quality system requirements related to sterilization and microbiological control.
Demonstrated ability to independently lead complex technical initiatives.
Experience supporting multiple manufacturing sites and contract sterilizers globally preferred.
Experience with multiple sterilization modalities and emerging novel sterilization technologies preferred.
Prior participation in regulatory inspections, technical audits, or standards committees preferred.
Ability to translate complex scientific concepts into clear, actionable guidance for technical and non-technical audiences.
Knowledge of ISO 11135, ISO 11138 series, ISO 11737, ISO 10993-7, ISO 14937, FDA requirements, and international requirements.
Strong problem-solving and analytical skills.
Strong collaboration skills.
Clear, concise technical communication.

Benefits

Comp & perks

Medical, dental, and vision insurance
401(k) with company match
Paid time off (PTO)
Additional employee wellness programs
Incentive compensation eligibility
Hybrid working arrangements