Senior Sterilization Engineer EO Facility Site Manager
Senior Sterilization Engineer EO Facility Site Manager
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1 Vacancy
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 youll 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:
- Bachelors 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 (CISSEO) 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.
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
