Maintenance Engineer - Sterilization

Description

Job Summary: Maintenance Engineer – Sterilization responsible for analyzing and optimizing ethylene oxide (EtO) sterilization cycles, ensuring compliance and safety. Key Highlights: 1. Analysis and optimization of ethylene oxide (EtO) sterilization cycles 2. Technical support to mechanical and electrical maintenance teams 3. Active participation in Management of Change (MOC) Now Job ID R\-543899 Category Engineering Location Fraga, Spain Region EMEA **We are the people who give possibilities purpose** ---------------------------------------------------- BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. **Job Description** =================== As a Maintenance Engineer \- Sterilization reporting to the Sterilization Area Supervisor, you will be responsible for analyzing and optimizing ethylene oxide (EtO) sterilization cycles, ensuring compliance with applicable safety, quality, and regulatory requirements. Your responsibilities will include technical evaluation of process parameters, analysis of deviations, support in investigations, as well as conducting and updating risk analyses (HAZOP, What If, FMEA) associated with facilities, equipment, and process changes. You will actively participate in Management of Change (MOC), evaluating the technical, safety, and regulatory impact of modifications to equipment, processes, or facilities within the sterilization area, distribution center, and internal logistics. Additionally, you will provide technical support to the mechanical and electrical maintenance team in preventive and corrective activities, serving as the technical reference for the process beyond operational execution. **Responsibilities:** * Participate in technical and multidisciplinary meetings, providing **technical expertise on ethylene oxide (EtO) sterilization processes**, defining action plans, assigning responsibilities, and tracking commitments made. * Analyze deviations, events, and losses related to the sterilization process and associated equipment, **providing technical support for root cause investigations** to ensure implementation of effective and sustainable corrective actions. * Conduct and participate in **process and facility risk analyses** (HAZOP, What If, FMEA), especially for critical systems utilizing EtO, utility services, and safety systems. * Lead and/or collaborate on **Management of Change (MOC)**, evaluating the technical, safety, quality, and regulatory impact of modifications to equipment, facilities, critical parameters, or process sequences. * Ensure **monitoring, control, and standardization of critical parameters (settings)** for sterilization equipment and associated systems, guaranteeing their integrity and traceability. * Provide technical input for the **continuous improvement of maintenance standards**, based on failure analysis, historical fault data, preventive activities (PPM/DTM), and process behavior. * Provide technical support for **facility expansion and modification projects**, defining technical, process safety, and EtO sterilization compatibility requirements. * Maintain up-to-date **electrical and mechanical engineering technical documentation** (drawings, schematics, process and critical utility diagrams). * Design and review **electrical schematics** and associated technical solutions for new developments or modifications to equipment and facilities. * Accurately and rigorously record maintenance activities, implemented changes, and relevant technical data in defined systems (SAP and GMP documentation). * Identify, communicate, and respond to **anomalies detected during preventive or corrective maintenance tasks** that could compromise process safety, product quality, or equipment availability. * Perform technical monitoring of **critical spare parts**, ensuring correct specification, usage, and traceability in sterilization equipment and auxiliary systems. * Provide technical support for **management of critical equipment failures**, ensuring appropriate escalation, subsequent analysis, and implementation of preventive actions. * Collaborate closely with **Quality, Laboratory, and EHS departments** to ensure compliance with **GMP, process safety, and applicable regulatory requirements** in the EtO sterilization environment. **Preferred Qualifications** * Technical or university degree in Engineering \- Chemical Engineering preferred. * Experience in similar positions * Advanced level of spoken and written English * Office applications * ERP systems (data entry in SAP, MES, etc.) * Excel/BI and chart generation / trend analysis. Salary range for this position: EUR 29\.000 \- EUR 36\.000 **Why Join Us?** ================ To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive. We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face\-to\-face collaboration supports your learning, your progress, and your success. **To learn more about BD visit** https://bd.com/careers. Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics. Required Skills Optional Skills . **Primary Work Location** ========================= ESP Huesca \- Fraga**Additional Locations** ======================== **Work Shift** ============== At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance\-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You." Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed. Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role. **Salary Range Information** €29,400\.00 \- €47,025\.00 EUR Annual