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.
Process Optimization & Innovation
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.
New Product & Change Suppor t
Provide sterilization design input for new products, packaging, materials, and manufacturing processes.
Lead or support complex sterilization impact assessments for product, process, and supplier changes.
Define testing strategies and acceptance criteria to support product adoption.
Regulatory & Compliance Suppor t
Ensure sterilization activities comply with applicable global standards and regulations, including but not limited to ISO 11135, ISO 11138 series, ISO 11737, ISO 10993-7, ISO 14937, and relevant FDA and international requirements.
Support internal and external audits and inspections as a technical subject matter expert.
Monitor changes to industry standards and regulations and translate them into practical, compliant implementation strategies.
Knowledge Sharing & Technical Mentorship
Develop and deliver technical training, guidance, and mentoring to internal Sterilization, Microbiology, and cross-functional teams.
Author, review, and approve high-impact technical documents, including protocols, reports, risk assessments, and technical justifications.
Serve as a corporate representative on relevant industry committees and working groups (e.g., AAMI) as appropriate.
Required 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.
Strong understanding of global regulatory and quality system requirements related to sterilization and microbiological control.
Demonstrated ability to independently lead complex technical initiatives.
Requirements
Experience supporting multiple manufacturing sites and contract sterilizers globally.
Experience with multiple sterilization modalities and knowledge of emerging novel sterilization technologies.
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.
NOTE: This position is eligible for hybrid working arrangements (requires on-site work from an
Additional Information
Job Summary
The Sterilization Staff Specialist is a senior technical expert and individual contributor responsible for providing scientific leadership and decision-making for global sterilization processes. This role serves as the organization's highest level of technical expertise for ethylene oxide (EO) sterilization and provides strategic expertise across alternate sterilization modalities, product residuals, and complex deviations and change assessments.
This position is critical to enabling product scalability, cycle optimization, risk reduction, and regulatory compliance while supporting new product introductions, site expansions, and continuous improvement initiatives. The Sterilization Staff Specialist operates with a high degree of autonomy and partners closely with Quality, Manufacturing, R&D, Supply Chain, and external sterilization vendors.
Insulet · US