Sterilization Engineer I

Eurofins USA BioPharma Services • San Jose, CA

3d • Onsite

About The Position

Eurofins Scientific is an international life sciences company providing analytical testing services. This role focuses on the development, validation, and ongoing control of Ethylene Oxide (EO) sterilization processes. The Sterilization Engineer will be responsible for designing and validating EO sterilization cycles according to ISO 11135 and internal procedures, defining process parameters, and supporting the transfer of processes to production. The position also involves monitoring process performance, conducting periodic reviews, identifying optimization opportunities, and ensuring compliance with regulatory requirements. Additionally, the role requires supporting investigations for deviations, preparing for audits, and providing technical expertise to cross-functional teams and customers.

Requirements

• Bachelor’s degree in Engineering or scientific discipline
• Knowledge of EO sterilization principles and ISO 11135
• Experience with validation, investigations, and quality systems
• Strong analytical and technical writing skills

Nice To Haves

• Experience in medical device, pharmaceutical, or contract sterilization environments
• Familiarity with FDA QSR, ISO 13485, and ISO 14971
• Prior EO-specific training or certifications

Responsibilities

• Develop EO sterilization cycles in accordance with ISO 11135 and internal procedures
• Plan, execute, and document sterilization validations (PQ)
• Define process parameters, acceptance criteria, and requalification requirements
• Support process transfers from development to routine production
• Monitor EO process performance and review routine cycle data and trends
• Perform periodic reviews and assess need for requalification or revalidation
• Identify and lead process optimization opportunities (efficiency, safety)
• Support implementation of equipment, process, or material changes through change control
• Ensure EO sterilization activities comply with ISO 11135, FDA, and customer requirements
• Lead or support investigations for EO-related deviations, nonconformances, and OOS events
• Perform root cause analysis and define effective CAPAs
• Prepare for and support internal audits, customer audits, and regulatory inspections
• Provide EO technical expertise to Operations, Quality and Customer Project Teams
• Communicate sterilization strategies, risks, and results to customers and internal stakeholders
• Support customer inquiries, technical reviews, and project planning activities
• Contribute to training and knowledge sharing related to EO sterilization

Benefits

• Comprehensive medical coverage
• dental
• vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees