Sterilization Engineer I

Company DescriptionEurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organizations. It also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products.In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralized and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.2025, Eurofins generated total revenues of EUR € 7.296 billion, and has been among the best performing stocks in Europe over the past 20 years.Job DescriptionEO 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 ImprovementMonitor 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 SupportEnsure 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 CollaborationProvide 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 sterilizationQualificationsRequired: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 skillsPreferredExperience in medical device, pharmaceutical, or contract sterilization environmentsFamiliarity with FDA QSR, ISO 13485, and ISO 14971Prior EO-specific training or certificationsAdditional InformationPosition 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 includingComprehensive 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.