As manufacturing specialist, you will support the production batches in the VLF (Vaccine Launch Facilities). You are the lead in solving acute problems, detecting abnormalities and implementation preventive actions. In parallel with these process and manufacturing activities, you are responsible as equipment owner for the corresponding production equipment, documentation and training. As manufacturing specialist, you work closely with your operations support team and within the other teams of the VLF.
Specific Tasks include:
- Taking part in activities related to the production support of cGMP batches in the launch facility. This includes processes such as waste disposal, storage of product in the freezer park, shipments, single use supply, fumigation of the VLF, sampling etcetera.
- Acute troubleshooting when problems occurred during production.
- Taking the lead in root cause investigations of complex deviations and for the implementation of preventive actions.
- The production documentation of the process equipment and batch records to ensure successful production runs can be produced.
- As equipment owner, that the production equipment is in validated state and well maintained, and that there is enough capacity for production to meet the production schedule.
- As equipment owner, the process equipment related reports and KPI’s. You will have the overview and knowledge of the status of the equipment (e.g. uptime, downtime, breakdowns, lifecycle management, occupancy rate and capacity.)
- Initiating and handling of compliance records (Change controls, events, CAPA, deviations, reports).
- Leading process excellence activities to continuously improve the work as well as personal skills.
Our client is part of an international company, and develops and manufactures biologicals aiming to treat diseases in the field of cardiology, immunology and oncology.
Functie-eisenWe are looking for candidates with the following skill set:
- Bachelor / Masters degree in biotechnology, biochemistry, biomedicine, process technology (or equivalent education).
- Process Engineer 2-4 years’ experience in a biotechnology or biopharmaceutical industry environment. 1-2 years for WO graduate
- Senior Process Engineer 4-8 years’ experience in a biotechnology or biopharmaceutical industry environment. 2-4 years for WO graduate
- Experience with cGMP environment and EHSS standards is required.
- Certified (Lean) Green Belt. Competences:
- High degree of accuracy, initiative, and independence.
- Innovative and exploring person which detect abnormalities.
- Flexible, can deal with changing priorities and stress-resistant.
- Enthusiastic team player.
- “Can do” attitude, critical and proactive.
- Practical technical understanding and conceptual thinking.
- Good communication in Dutch and English, both verbally and in writing. Good communication and alignment on issue or change management
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You will be part of a dynamic and accomplished team. We offer an employment of 32 to 40 hours a week with excellent primary and secondary benefits. Moreover, Modis offers interesting benefits, like participation of our company-fitness-plan. Modis stands for innovation and stimulates new ways of working. Next to a lot of freedom, you will get the necessary amount of responsibilities, combined with the possibility to develop your ambitions and expertise. Together, we can grow.
I want to apply now
Please tell us who you are and what motivates you! We expect you to elaborate on your experience in late stage development and industrial experience. Send us your application using the application button on this website. Send us your CV + motivationletter before 26 May 2020
If you wish to receive more information first, please contact us on email@example.com or contact one of our Recruitment Consultants:
Barbara Flaton 06-2266 4285
Lars Wijnands 06-1333 9633
Cindy van Gorp 06-1278 1269