About this role
EO Sterilization Process Design and Validation:
Develop EO sterilization cycles in accordance with ISO 11135 and internal proceduresPlan, execute, and document sterilization validations (PQ)Define process parameters, acceptance criteria, and requalification requirementsSupport process transfers from development to routine productionOngoing Process Control and Continuous Improvement
Monitor EO process performance and review routine cycle data and trendsPerform periodic reviews and assess need for requalification or revalidationIdentify and lead process optimization opportunities (efficiency, safety)Support implementation of equipment, process, or material changes through change controlCompliance, Investigations, and Audit Support
Ensure EO sterilization activities comply with ISO 11135, FDA, and customer requirementsLead or support investigations for EO-related deviations, nonconformances, and OOS eventsPerform root cause analysis and define effective CAPAsPrepare for and support internal audits, customer audits, and regulatory inspectionsTechnical Support and Cross-Functional Collaboration
Provide EO technical expertise to Operations, Quality and Customer Project TeamsCommunicate sterilization strategies, risks, and results to customers and internal stakeholdersSupport customer inquiries, technical reviews, and project planning activitiesContribute to training and knowledge sharing related to EO sterilization Required:
Bachelor’s degree in Engineering or scientific disciplineKnowledge of EO sterilization principles and ISO 11135Experience with validation, investigations, and quality systemsStrong analytical and technical writing skillsPreferred:
Experience in medical device, pharmaceutical, or contract sterilization environmentsFamiliarity with FDA QSR, ISO 13485, and ISO 14971Prior 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 optionsLife and disability insurance401(k) with company matchPaid vacation and holidaysEurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.