Eurofins Medical Device seeks a technical expert in sterilization to lead validation and sterility assurance systems from R&D through commercial scale at our Lancaster, PA headquarters. You’ll oversee sterilization validation programs (especially across two or more modalities), ensure regulatory compliance, consult on packaging and material compatibility, and mentor both internal colleagues and our facility in San Jose, CA as well as, Eurofins clients. Your role will significantly influence client engagement and help shape sterilization excellence across the organization.Key ResponsibilitiesLead sterilization strategy and validation for two or more modalities: e.g. EtO, gamma/X‑ray, e‑beam, steam, VHP or dry heat, ensuring compliance with ISO 11135, ISO 11137, ISO 14937, ISO 17665, ISO 11737, and relevant regulations (ISO 13485, FDA QSR, cGMP/GLP/GDP).Develop and manage IQ/OQ/PQ protocols for sterilization and sterile packaging validations.Evaluate material compatibility and define sterile packaging strategies effective across selected sterilization modalities. Assist in identifying testing required.Act as Subject Matter Expert for at least two sterilization technologies—delivering technical guidance, driving EO regulatory compliance, and liaising across teams and external partners.Support bioburden and environmental monitoring programs in cleanroom environments (ISO 14644; ISO 11737). Advise clients on interrelations of the sterilization development and process including validations, testing, change evaluations, etc.Develop and support cleanroom validation methodologies and environmental monitoring programs. Lead client engagement to define validation plans for complex or hard-to-sterilize products, including new product development support.Support regulatory matters including EPA NESHAP, TRI, and state reporting in an expert capacity, support San Jose site.Participate in internal/external audits; support CAPAs, change controls, and continuous improvement initiatives.Mentor and train staff and colleagues on sterilization theory, validation best practices, and operational excellence.Represent Eurofins in technical reviews, client meetings, and industry forums (e.g. AAMI, EOSA).
