Filling Line Operator

Job description

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. 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. Working at PSS means working with highly motivated people with a can-do mentality. Our people work in an international environment, within an enthusiastic team and for an organization where there is sufficient room to develop further. Working together is extremely important to us and having fun in what you do is part of that! Our monthly team lunches, team activities and the hand out of awards to our colleagues are an example of this. We also offer: A responsible and challenging position within the team; Plenty of room for your own ideas and input; Specialist training and a range of opportunities for personal and professional development; Online preventive mental health platform; Flexible working hours; Good salary and benefits. Working at PSS offers you the flexibility and personal touch of working in a medium sized and dynamic company, whilst also allowing you to benefit from having Eurofins as a parent company. Our ambitious growth plans provide ample opportunities for the motivated employees: Plenty of opportunities for growth; Varied work where you are in regular contact with other companies and scientists within the Eurofins group; A broad customer portfolio ensuring a lot of diversity in your work. Would you like to know more? For questions regarding the position, please follow the link below ‘I’m interested’ in order to contact the hiring manager. Acquisition for this vacancy is not appreciated. Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies. In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 62,000 staff across a network of more than 1000 independent companies in over 62 countries and operating more than 900 laboratories. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing. In 2025, Eurofins generated total revenues of EUR € 7.296 billion, and has been among the best performing stocks in Europe over the past 20 years. 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. If you're an employee seeking an exceptional career journey, Eurofins PSS Insourcing Solutions® is your gateway to a future where innovation, collaboration, and success converge. Join us in a world where excellence knows no boundaries!