Sterilization Engineer I

EO Sterilization Process Design and Validation:

• 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

Ongoing Process Control and Continuous Improvement

 

• 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

Compliance, Investigations, and Audit Support

 

• 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

Technical Support and Cross-Functional Collaboration

 

• 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

Required:

• 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

Preferred:

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

Position is full-time, Monday-Friday 8am-4:30pm, plus additional hours, as needed. Candidates within a commutable distance of San Jose, CA are encouraged to apply.

Salary range is $25/h - $28/h depending on related experience.

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.