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 & 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.

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.

Would you like to know more
For questions regarding the position please follow the link below Im interested in order to contact the hiring manager.

Acquisition for this vacancy is not appreciated.

Remote Work :

No

Employment Type :

Full-time