Staff Sterilization Specialist (Hybrid, Acton MA)
Core
Senior technical expert providing scientific leadership and decision-making for global sterilization processes, specifically ethylene oxide (EO) and alternate modalities.
Role type
Staff Sterilization Specialist (Senior IC)
Builds
Sterilization processes, cycle optimizations, and compliance strategies for medical devices.
Domain
Medical device manufacturing / Sterilization science
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
EO sterilization expertise, validation and requalification, deviation management, regulatory compliance knowledge, risk assessment, process optimization, technical mentorship
Preferred skills
Multi-site manufacturing experience, knowledge of emerging sterilization technologies, audit participation, scientific communication
Technologies
Ethylene oxide (EO), Radiation, Vaporized Hydrogen Peroxide (VHP)
Responsibilities
Lead cycle development, optimization, and validation for EO sterilization; Provide expert guidance on alternate sterilization modalities; Act as escalation point for complex deviations and root cause analyses; Lead initiatives to optimize cycles and reduce residuals; Provide sterilization design input for new products and packaging; Ensure compliance with global standards (ISO, FDA); Develop technical training and author high-impact documents.
Seniority
Staff, hands-on IC with strategic scope