Yacht Life Sciences has a vacancy for a Manufacturing Specialist Operations Support at the Vaccine Launch Facility (VLF) of Janssen Biologics B.V. in Leiden.

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 operations support team and within the other teams of the VLF.

As Manufacturing Specialist Operations Support, you will be responsible for: 

• 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, CPA, deviations, reports).
• Leading process excellence activities to continuously improve the work as well as personal skills.