Filling Line Operator

For our team in Leiden, we are looking for a Filling Line Operator who can perform operational activities within a GMP-regulated production environment, with a primary focus on aseptic Fill & Finish. In this role, you will contribute to the production of advanced therapeutics and support safe, compliant and efficient manufacturing within a cleanroom environment.

You will be involved in the preparation, operation and monitoring of the aseptic filling line and isolator, while also performing or supporting upstream and downstream process steps where required. Besides routine manufacturing activities, you will also support aseptic process simulations (APS), qualification and engineering runs, troubleshooting, GMP documentation and continuous improvement activities.

Tasks and Responsibilities:

• Preparing, setting up, operating, monitoring and shutting down the aseptic filling line and isolator, including decontamination, glove testing, cleaning and line clearance;
• Performing or supporting upstream and downstream processing activities where required;
• Performing routine and non-routine interventions and supporting environmental monitoring and in-process controls;
• Participating in APS campaigns, qualification activities, water runs, engineering runs and GMP manufacturing campaigns;
• Supporting material transfers, product handling and reconciliation activities;
• Completing and reviewing GMP documentation, including batch records, logbooks, forms and electronic records;
• Supporting non-conformances, investigations, root cause analyses, CAPAs, change controls and risk assessments;
• Contributing to qualification, validation, engineering and continuous improvement activities, including updates to work instructions and procedures;
• Maintaining required training and operator qualifications and working according to GMP, EHS, biosafety and aseptic processing requirements.