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.

• Leiden, Netherlands
• Full-time

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.

Qualifications

• MLO, HLO or BSc/MSc degree in Biotechnology, Biochemistry, Life Sciences or another relevant scientific or technical field;
• Experience in a production, laboratory or cleanroom environment. Experience with aseptic processing, Fill & Finish, upstream or downstream processing, or another GMP-regulated manufacturing environment is preferred;
• Understanding of GMP and the importance of accurate documentation, data integrity and contamination control;
• Experience with GMP documentation, deviations, CAPAs, change controls, qualification activities or process improvements is a plus;
• Able to work accurately and methodically according to written procedures and established quality standards;
• Comfortable combining hands-on operational activities with documentation, investigations and process improvement tasks;
• Takes ownership of assigned activities, identifies issues and raises concerns when quality, safety or compliance may be impacted;
• Comfortable working in a dynamic environment and able to collaborate effectively with Operations, QA, QC, Engineering and other disciplines;
• Fluent in English, both spoken and written.

Additional Information

Working at PSS means working in a team where people support each other, take responsibility for their work and stay closely connected to the client environment they work in. You will be part of an international setting, with colleagues who value clear communication, teamwork and a good working atmosphere.

We believe it is important that people can keep developing in their role. That is why we offer specialist training and opportunities to build your knowledge and skills further. We also make time to stay connected as a team, for example through monthly team lunches, team activities and moments where colleagues are recognized for their contribution. We offer:

• A responsible position within the team;
• Room to share your ideas and input;
• Specialist training and opportunities for personal and professional development;
• 31 vacation days per year based on a full-time employment contract, with the option to purchase 5 additional days;
• The option to use gross/net benefit schemes for sports and the purchase of a bicycle;
• Access to an online preventive mental health platform;
• A flexible start time between 07:00 and 09:00, depending on team planning and operational needs;
• A suitable salary and additional benefits.

Eurofins PSS Insourcing Solutions® is a global, award-winning insourcing solution. We place our skilled team directly at the client site, managing operations seamlessly and eliminating complexities. We ensure a strategic, long-term service commitment that delivers value directly at the client' site, utilising their facilities, equipment, and methodologies, while maintaining the same service, expertise, and cGMP compliance available at the Eurofins facility.

Working at PSS gives you the personal approach of a medium-sized organization, with the wider network and structure of Eurofins as a parent company. In your work, you regularly interact with other companies and scientists within the Eurofins group, which brings variety to the role.

This also means there may be opportunities to grow, depending on your role, experience and development.