NL - Manufacturing Specialist

Johnson & Johnson Worksense (via Randstad Sourceright) is responsible for finding, engaging and contracting talent for the Johnson & Johnson contingent workforce.

Janssen Biologics B.V. is one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and is focused on the development, production and marketing of vaccines and antibodies to prevent and combat infectious diseases. At the Leiden Site, talented and multi-scaled people are working in a dynamic culture in which innovation and a 'can do' state of mind are the central points. 

Would you like to be directly involved in the fight against the global  

"Corona virus" (COVID-19) pandemic? Then keep reading!

The Vaccines Launch Facility:

The Vaccine Launch Facility (VLF) is a state-of-the-art vaccines GMP manufacturing facility located at the Bioscience park in Leiden, where we produce vaccines against infectious diseases, such as Covid19, HIV and RSV. The VLF is designed to manufacture drug substance on a 1000 L scale for Phase III and commercial purposes. As a response to the global COVID-19 pandemic the VLF is one of the production sites for Janssen’s lead vaccine candidate for COVID-19.

Department:

The Centre of Expertise (CoE) plays a central role within the VLF, divided in two expertise: 1) Single use technology and 2) Manufacturing systems specialism for USP and DSP. The CoE is responsible for batch continuation by troubleshoot & support in production, robust and availability of process equipment. The CoE is key in clear translation of strategic and tactic projects to a workable process and environment for the shop floor. We always work against the high-quality standards and safety and compliance regulations that are applicable for vaccine manufacturing.

CoE is responsible to support the production teams with specialized and in-depth knowledge and skills on our production processes. The Centre of Expertise (COE) is a team of around 15 people.

Job Description:

As 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 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.

Qualifications:

• Bachelor degree in biotechnology, biochemistry, biomedicine, process technology (or equivalent education).
• Manufacturing specialist 4-8 years’ experience in a biotechnology or biopharmaceutical industry environment.
• 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.

Competences:

• 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.
• Good communication and alignment on issue or change management.
• Flexible in working acute troubleshooting with beeper from home (nights and weekends by circulation schedule).

EXTRA INFORMATION:

• You will work on-site in Leiden. You can check n with a colleague so you can also work from home, but there must always be someone on-site.
• This is a contracting position, with the possibility of an extension after the end date. You will receive a contract via our partner YACHT. They can offer you a contract for the duration of the assignment at J&J, a one year contract or a freelance contract (ZZP).