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Eurofins · 3 months ago

Senior Sterilization Engineer / EO Facility Site Manager

San Jose, CA, USA

Full-time

Onsite

Senior Level

5+ years exp

Eurofins is an international life sciences company providing a range of analytical testing services. They are seeking a Senior Sterilization Engineer / EO Facility Site Manager to lead operations at their Ethylene Oxide sterilization facility, overseeing sterilization validation projects and ensuring regulatory compliance.

BiotechnologyGeneticsHealth CareLife SciencePharmaceutical

Responsibilities

Lead EO sterilization validation projects from protocol development through execution and reporting (IQ/OQ/PQ)

Serve as the Subject Matter Expert (SME) for EO sterilization, offering technical and scientific guidance across the organization

Design, validate, and maintain EO sterilization processes in compliance with ISO 11135, FDA, EPA, and other applicable standards

Support new product development through sterilization and microbiology strategy development

Oversee day-to-day operations of the EO facility, including equipment maintenance, inventory, documentation, and quality system compliance

Collaborate with clients to create tailored validation plans for complex or hard-to-sterilize devices

Author, review, and manage technical documents including protocols, validation reports, and regulatory submissions

Act as the regulatory lead for EPA NESHAP, TRI and State reporting and compliance requirements

Participate in internal and external audits, supporting continuous improvement and corrective action efforts

Mentor and train staff on sterilization procedures, validation, and regulatory best practices

Represent Eurofins in client meetings, technical reviews, and industry conferences such as AAMI, EOSA, and others

Qualification

EO sterilization expertiseSterilization validationRegulatory complianceCISS–EO certificationISO 11135 knowledgeAnalytical skillsMicrosoft Office proficiencyCommunication skillsOrganizational skills