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

As an (Associate) Manufacturing Specialist, you will be responsible for the assigned equipment to be available and robust to meet the VLF production schedule. This includes direct support and leading the root cause analysis for operations whenever there is an issue, as well as improving the documentation, training and procedures related to the equipment. You will work closely with the manufacturing operators, GMP specialists, Maintenance department, Quality department, and process engineers.

 As a (Associate) Manufacturing Specialist, you will be responsible for: 

• 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.

Note: In general, the Associate role will merely have ownership on less complex systems and supports the manufacturing specialists in complex issues or priority projects.