Descripción de la oferta
We are looking for an Aseptic Process Expert to join our team, at our site based in El Masnou. Reporting to the QA Operations Head, you will play a key role in ensuring the highest standards of sterility, quality, and operational excellence across our manufacturing processes. You will act as a technical reference for aseptic practices, driving continuous improvement and supporting cross-functional teams to maintain robust and compliant operations. In this role, you will: • Lead and actively participate in cross-functional aseptic governance, providing technical expertise and driving continuous improvement of aseptic behaviors across manufacturing operations. • Identify and implement process optimization opportunities to enhance operational excellence, product quality, and compliance with global standards. What will you do? ✏ • Serve as the primary technical point of contact for manufacturing operations, providing operational and strategic support to ensure safe, timely, and compliant batch execution. • Strengthen aseptic culture by developing technical competencies and guiding teams in unplanned or challenging situations. • Foster strong collaboration between Manufacturing, Quality, and Maintenance to maintain aseptic integrity and operational reliability. • Lead the site’s Aseptic Process Simulation (APS) strategy, including the design, planning, execution, and documentation of the Annual APS Program in alignment with GMP and regulatory expectations. • Author and approve APS rationales, protocols, and reports, ensuring data integrity and technical robustness. • Coordinate with QA to ensure proper monitoring of aseptic behaviors during APS execution across shifts. • Lead and support investigations related to aseptic processes, ensuring timely root cause analysis and effective CAPA implementation, while monitoring CAPA effectiveness through GMP systems. • Collaborate with global and local Quality teams to share learnings and ensure alignment with best aseptic practices. What are we looking for? • At least 3 years of previous experience managing aseptic processes • Previous experience managing aseptic process simulations • High level of English and Spanish What do we offer? • Working Hours: Flexible schedule, with start time between 7:30 and 9:30 a.m. and end time between 4:00 and 6:00 p.m. • Medical Insurance • Life and Accident Insurance • Subsidized Canteen • Pension Plan • Remote Work: One day week
