Thermal Project Engineer

Description

Company: B. Braun Surgical, S.A.U. Job Posting Location: Rubí, Barcelona, Spain Functional Area: Other Areas Working Model: Hybrid Requisition ID: 12475 B. Braun seeks to hire a **Sterilization Engineer** to join the team responsible for designing, developing, and continuously improving ethylene oxide (EO) sterilization processes. The selected candidate will play a key role in defining sterilization cycles (recipes), executing re-qualifications, and ensuring regulatory compliance. Additionally, they will **lead development, optimization, and process transfer projects**, coordinating multidisciplinary teams while guaranteeing adherence to timelines, quality standards, and regulatory requirements. Furthermore, they will collaborate on technical knowledge of sterilization equipment and its peripherals. **Responsibilities:** * Design, development, and optimization of EO sterilization cycles. * Execution of **validations and re-qualifications** (IQ/OQ/PQ). * Process data analysis and definition of continuous improvement strategies. * Management of changes associated with sterilization processes. * Preparation of technical documentation (protocols, reports, SOPs). * Support for internal and external audits (GMP, ISO 11135\). * Leadership of sterilization process improvement, transfer, or implementation projects. * + Project planning, monitoring, and control (scope, timelines, risks). + Management of technical risks associated with sterilization processes. + Communication with internal stakeholders and, where applicable, external stakeholders. + Preparation and presentation of project results and progress updates. * Collaboration on technical knowledge of sterilization equipment and peripherals: * + Sterilization chambers + Vacuum systems, steam generators * + Gas injection and treatment systems * Cross-functional collaboration with other departments (Quality, Production, Maintenance, Regulatory). **Requirements:** **Education*** Bachelor’s degree in Engineering (Industrial, Chemical, Biomedical, or related field). * Specific training in sterilization and/or pharmaceutical/medical device processes is desirable. **Experience*** Minimum **2\-3 years of experience** in: * + Sterilization processes (preferably EO). + Industrial process validations. * Experience in regulated environments (GMP, ISO, FDA) is highly valued. * Experience participating in or leading technical projects is an advantage. **Technical Knowledge*** Knowledge of: * + Process validation (IQ/OQ/PQ). + Ethylene oxide sterilization and ISO 11135 standard (desirable). + Regulated environments (GMP, ISO). * + Basic statistical analysis applied to processes. + Risk management (FMEA desirable). * General understanding of: * + Industrial processes and variable control. + Data analysis (Excel or other tools). * Proficiency with tools: * + Advanced Excel or data analysis software. + Planning tools (e.g., MS Project) * Desirable knowledge of equipment: * + Sterilization chambers. * + Vacuum systems, steam generators * + Gas injection and treatment systems. * + SCADA or PLC control software **Competencies*** Analytical ability and problem-solving skills. * Technical rigor, attention to detail, and quality orientation. * Ability to work effectively in multidisciplinary teams. * Proactivity and commitment to continuous improvement. * Capacity for technical learning. * Effective communication skills, including technical presentations. * Leadership and influence without direct authority. * Task organization and prioritization. * Results orientation and adherence to deadlines. **Languages*** Spanish: native or bilingual. * English: advanced level (oral, reading, and technical writing). **Additional assets*** Experience in ethylene oxide sterilization. * Knowledge of sterilization equipment and auxiliary systems. * Participation in regulatory audits. * Experience in the pharmaceutical or medical device industry. **We offer:** Annual gross salary starting from 50\.600€, adjusted according to the candidate’s profile and experience. Regarding the position: * Integration into a highly specialized technical environment. * Involvement in strategic and high-impact projects. * Professional development within a highly specialized area. * Continuous training. * Collaborative and multidisciplinary environment. And to help you perform at your best, our proposal places your well-being, development, and experience as a member of our team at its core: * Hybrid work model * Flexible compensation * Life and accident insurance * Shuttle bus and parking * Pension plan * Financial assistance * Emotional Well-being Service * Free health check-ups * B. Braun Savings Club * Digital Disconnection Protocol * Sports and social activities **Choose the B, choose B. Braun** B. Braun Surgical, S.A.U. \| Soledad Barragán López