Aseptic Process Expert

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