Operator USP/DSP

For our team in Leiden, we are looking for an Operator with experience or clear affinity in bioprocessing within a GMP-regulated environment. In this role, you will contribute to the production of advanced therapeutics and support the scale-up of new products toward clinical and commercial readiness.

This position is broader than a purely hands-on manufacturing role. In addition to executing operational activities in the cleanroom, you will also contribute to GMP documentation, process-related investigations, and continuous improvement initiatives. This makes the role suitable for candidates who combine practical bioprocessing knowledge with the ability to understand and support the quality and documentation side of GMP-manufacturing.

You will work in a cleanroom environment under GMP guidelines, and your responsibilities may include:

• Executing upstream processing activities, including bioreactor assembly, fermentation and process monitoring;
• Executing downstream processing activities, such as filtration and chromatography;
• Supporting fill line activities where applicable;
• Performing in-process checks and ensuring production steps are executed according to procedures and specifications;
• Reviewing and completing GMP documentation, including batch records, logbooks and data entry;
• Supporting or handling deviations, non-conformances, change controls and CAPAs;
• Updating or improving work instructions and SOPs;
• Contributing to deviation investigation reports and other GMP-related documentation;
• Participating in process improvements, operational excellence initiatives and cross-functional projects;
• Supporting 5S and general cleanroom compliance activities.