Our client is one of the global leader in healthcare and pharmaceutical products, with base in Leiden. The company focuses on the discovery, development, manufacture, and marketing of vaccines to protect people worldwide from infectious diseases.
Responsible for the assigned equipment to be available and ready to meet the facility production schedule + taking the lead in root cause investigations of deviations and for the implementation of preventive actions
- Acute troubleshoot & support production of cGMP batches in the VLF. This includes processes such as cell and virus culture, purification processes, formulation & fill and in-process testing.
- Taking the lead in root cause investigations of complex deviations and for the implementation of preventive actions.
- Initiating and handling of compliance records (change control, events, CAPA, deviations).
- Initiate, and execution of test protocols that help to improve the system or process.
- Working precisely, detecting and solving acute problems and communicate possible abnormalities.
- As equipment owner, that the production equipment is in validated state, documentation is up to date, well maintained, and capacity meets planning.
- 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.)
- Leading process excellence activities to continuously improve the work as well as personal skills.
- Bachelor degree in biotechnology, biochemistry, biomedicine, process technology (or equivalent education).
- Associate manufacturing specialist 2-4 years’ experience in a biotechnology or biopharmaceutical industry environment. 1 -2 years for WO graduate
- Manufacturing specialist 4-8 years’ experience in a biotechnology or biopharmaceutical industry environment. 2 -4 years for WO graduate
- Expert in cell culture (USP), bioreactors, virus propagation and/or downstream processing (DSP).
- Experience with cGMP environment and EHSS standards is required.
- Certified Lean Yellow Belt, preferably Green Belt.
For more information please contact Guilherme Tokunaga at firstname.lastname@example.org or +31 (0) 20 658 98 01.