Eurofins BioPharma Product Testing North America · 4 hours ago
Ethylene Oxide Facility Site Manager
San Jose, CA
Full-time
Onsite
Senior Level
$130K/yr - $170K/yr
5+ years expEurofins Scientific is an international life sciences company offering a wide range of analytical testing services. The Senior Sterilization Engineer / EO Facility Site Manager will lead operations at the Ethylene Oxide sterilization facility, overseeing validation projects and ensuring regulatory compliance while optimizing facility operations.
Biotechnology
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
Required
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
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
Preferred
Managerial experience preferred
Certified Industrial Sterilization Specialist (CISS–EO) certification strongly preferred
Benefits
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
Company
Eurofins BioPharma Product Testing North America
Eurofins BioPharma Product Testing is the largest network of harmonized bio/pharmaceutical GMP product testing laboratories worldwide providing comprehensive laboratory services for the world's largest pharmaceutical, biopharmaceutical and medical device companies.
1001-5000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase