Eurofins
Senior Sterilization Engineer / Ethylene Oxide Facility Site Manager
Eurofins, San Jose, California, United States, 95199
Senior Sterilization Engineer / Ethylene Oxide Facility Site Manager
Full-time
Compensation: USD 130,000 - USD 170,000 - yearly
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.
The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organizations. It also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products.
In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralized and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.
In 2024, Eurofins generated total revenues of EUR € 6,515 billion, and has been among the best performing stocks in Europe over the past 20 years.
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.
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.
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.
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Compensation: USD 130,000 - USD 170,000 - yearly
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.
The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organizations. It also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products.
In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralized and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.
In 2024, Eurofins generated total revenues of EUR € 6,515 billion, and has been among the best performing stocks in Europe over the past 20 years.
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.
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.
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.
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