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

Qualifications :

Required:

• Bachelors 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

Additional Information :

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.

Remote Work :

No

Employment Type :

Full-time