Job Description

Position Overview

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.

Key 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.

Qualifications

Education:

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

Experience:

• 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.

Skills & Capabilities:

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

Additional Information

Position is full-time, Monday - Friday, 9:00am - 5:00pm. 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 BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.