Sterilization Engineer I
Eurofins BioPharma Product Testing North America, San Jose, CA, United States
Job Description
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 Qualifications
Bachelor’s degree in Engineering or a scientific discipline
Knowledge of EO sterilization principles and ISO 11135
Experience with validation, investigations, and quality systems
Strong analytical and technical writing skills
Preferred Qualifications
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 8:00am – 4:30pm, with additional hours as needed. Candidates within a commutable distance of San Jose, CA are encouraged to apply.
Salary: $25.00 – $28.00 per hour, depending on related experience.
Benefits include:
Comprehensive medical coverage, dental, and vision options
Life and disability insurance
401(k) with company match
Paid vacation and holidays
Equal Employment Opportunity Statement
Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.
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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 Qualifications
Bachelor’s degree in Engineering or a scientific discipline
Knowledge of EO sterilization principles and ISO 11135
Experience with validation, investigations, and quality systems
Strong analytical and technical writing skills
Preferred Qualifications
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 8:00am – 4:30pm, with additional hours as needed. Candidates within a commutable distance of San Jose, CA are encouraged to apply.
Salary: $25.00 – $28.00 per hour, depending on related experience.
Benefits include:
Comprehensive medical coverage, dental, and vision options
Life and disability insurance
401(k) with company match
Paid vacation and holidays
Equal Employment Opportunity Statement
Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.
#J-18808-Ljbffr