Filling Line Operator

Eurofins Scientific - Nederland; Leiden; On-site; EUR 40,000 - 60,000; Full time

Benefits offered by this job

Specialist training

Flexible working hours

Room for ideas

Competitive salary and benefits

Job summary

Eurofins Scientific in Leiden, Netherlands, is seeking a Filling Line Operator for aseptic Fill & Finish in a GMP-regulated production environment. You will operate, monitor and support the aseptic filling line and isolator, contribute to upstream/downstream steps, and assist with APS campaigns and GMP documentation.

Fluency in English and a relevant science degree are required; experience in cleanrooms and GMP environments is preferred, with a hands-on, precise approach and teamwork across QA,

Qualifications

• Must have MLO, HLO or BSc/MSc in Biotechnology, Biochemistry, Life Sciences or a related field.
• Experience in a production, laboratory or cleanroom environment; aseptic processing preferred.
• GMP knowledge, documentation discipline, data integrity and contamination control.
• Experience with GMP documentation, deviations, CAPAs or change controls is a plus.
• Able to work accurately according to written procedures and quality standards.
• Ability to balance hands-on operations with documentation and process improvement tasks.
• Shows ownership, identifies issues and communicates quality/safety concerns.
• Fluent in English, both written and spoken.

Responsibilities

• Prepare, set up, operate, monitor and shut down the aseptic filling line and isolator, including decontamination and cleaning.
• Perform or support upstream and downstream processing activities as required.
• Carry out routine and non-routine interventions and support environmental monitoring and in-process controls.
• Participate in APS campaigns, qualification activities, water runs and GMP manufacturing campaigns.
• Support material transfers, product handling and reconciliation activities.
• Complete GMP documentation, including batch records and logbooks.
• Support non-conformances, investigations, CAPAs, change controls and risk assessments.
• Contribute to qualification, validation, engineering and continuous improvement activities.
• Maintain training and operator qualifications per GMP, EHS and aseptic processing requirements.

Skills

GMP compliance

Documentation

Attention to detail

Team collaboration

English proficiency

Education

MLO/HLO or BSc/MSc in Biotechnology/ Life Sciences

Job description

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.

For our team in Leiden, Netherlands, 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.

• 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 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.

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.