Ethylene Oxide Sterilization Engineer I

EurofinsSan Jose, CA
$25 - $28Onsite

About The Position

Eurofins Scientific is an international life sciences company providing a unique range of analytical testing services. The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization services. Eurofins generated total revenues of EUR € 7.296 billion in 2025 and has been among the best performing stocks in Europe over the past 20 years. This role focuses on Ethylene Oxide (EO) Sterilization Process Design and Validation, Ongoing Process Control and Continuous Improvement, Compliance, Investigations, and Audit Support, and Technical Support and Cross-Functional Collaboration.

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
  • holidays
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