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.
Assisting the operations department by planning production support, logistics tasks and continuous improvement of the operation processes. This will also involve deviation management and troubleshooting when problems arise during production.
• 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.
• Bachelor’s degree or higher in biotechnology, biochemistry, biomedicine, process technology (or equivalent education).
• 3-5 years’ experience in a biotechnology or biopharmaceutical industry environment.
• Experience with cGMP environment and EHSS standards is required.
• Certification Lean Yellow or Green Belt. is a big plus
Are you interested and want to apply for this role? Please fill out your application via the apply button below and contact Guilherme Tokunaga at +31 (0) 20 658 98 01 or email@example.com.
GMP Manufacturing Specialist