Ethylene Oxide Facility Site Manager

Senior Sterilization Engineer / EO Facility Site Manager

Eurofins Medical Device is seeking a highly motivated and experienced Senior Sterilization Engineer / EO Facility Site Manager to lead operations at our Ethylene Oxide (EtO)(EO) sterilization facility in San Jose, CA. This is a hands‑on leadership role ideal for a technical expert with deep knowledge of EtO sterilization and a passion for driving results. You will oversee the full lifecycle of sterilization validation projects, ensure regulatory compliance, and collaborate with cross‑functional teams to deliver high‑quality service to our clients.

In this role, you’ll be instrumental in optimizing facility operations, managing client engagements, mentoring on‑site staff, and helping shape the future of sterilization excellence at Eurofins.

• 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.

• Bachelor’s degree in science, engineering, microbiology, or a related technical discipline.

• Minimum 5 years in sterilization or a highly regulated environment (medical device industry preferred).
• At least 2 years of direct experience in sterility assurance.
• Managerial experience preferred.
• Certified Industrial Sterilization Specialist (CISS–EO) certification strongly preferred.
• In‑depth knowledge of EO sterilization regulations and standards, including ISO 11135, cGMP, FDA, and EPA NESHAP.
• Experience with validation, quality assurance, document control, and regulatory submissions in a laboratory or manufacturing environment.

• Strong analytical and problem‑solving skills.
• Excellent verbal and written communication abilities.
• Proficiency in Microsoft Office (Word, Excel).
• Highly organized, detail‑oriented, and proactive.

Position is full‑time, Monday – Friday, 9:00 am – 5:00 pm. Candidates currently living within a commutable distance of San Jose, CA are encouraged to apply.

• Excellent full‑time benefits including comprehensive medical coverage, dental, and vision options.
• Life and disability insurance.
• 401(k) with company match.
• Paid vacation and holidays.

Eurofins USA Bio Pharma Services is a Disabled and Veteran Equal Employment Opportunity employer.