As manufacturing specialist, you will support the production batches in the VLF. 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 fellow Manufacturing specialist in the COE and process engineers and Sr manufacturing operators within the other teams of the VLF.
As Manufacturing Specialist, you will be responsible for:
- Taking part in activities related to the production of cGMP batches in the launch facility. This includes processes such as cell and virus culture, purification processes, fill and in-process testing.
- 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, CPA, deviations, reports).
- Leading process excellence activities to continuously improve the work as well as personal skills.
- Bachelor’s degree in biotechnology, biochemistry, biomedicine, process technology (or equivalent education).
- 6-8 years’ experience in a biotechnology or biopharmaceutical industry environment.
- Expert in cell culture (USP), bioreactors, virus propagation and downstream processing (DSP).
- Experience with cGMP environment and EHSS standards is required.
- Certified Lean Yellow Belt, preferably Green Belt.
- 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.
- Flexible in working acute troubleshooting with beeper from home (nights and weekends by
Please apply directly online via Mycareeropportunities (MCO). (vacancy number: 1905789677W Manufacturing Specialist)
Janssen Biologics (7266)