Johnson and Johnson

Johnson & Johnson / Viral Launch Facility / OPERATIONS is looking for a senior operator, building our drug product capability

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without diseases. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and hearts to pursue the most promising science into life changing product for patients around the globe. One of the key focus area’s for Janssen in Leiden is the development and production of Gene Therapeutic products to cure chronic diseases.

At the Janssen site in Leiden (located at the Bioscience Park), we work with more than 2400 talented and multi-skilled people in 5 different business units. We produce different product and pioneer solutions to deliver better health. This vacancy is for Business Unit 2: The Viral Launch Facility (VLF).

The VLF is Janssen’s state-of-the-art GMP manufacturing facility from which we launch and grow new and innovative Gene Therapeutic products. The facility has two manufacturing suites. In suite 1 we produce Drug Substance (e.g. cell & virus cultivation and purification processes) and in suite 2 we produce Drug Product (e.g. Fill & Finish processes) for the final product.

Both production suites in the VLF are currently in the final stage of preparation for Phase 3 and commercial production to accommodate the transfer of new products to the VLF per 2024.

Are you excited to set up a plant with new equipment and scale up the processes within a global company? Do you get energy from working together and contribute to improve the life of patients?

Then this is your job!

Job Summary

You will become part of the Operations department. This department is responsible for on-time manufacturing and delivery of the planned batches against the high-quality standards and safety and compliance regulations that are applicable for Janssen’s product portfolio for Gene Therapeutic products.

The operation department is divided into different teams. There are manufacturing teams for Drug Substance production and manufacturing teams for Drug Product filling, consisting of Manufacturing operators. The Manufacturing Operators are responsible for the actual on-time production, filling and delivery of the products.

Additional there is a General Operations Team consist of Manufacturing specialists, GMP specialists, a planner and Operations Engineers with in-depth operation knowledge and are responsible for GMP, inspections, planning and project support within the operations and the other VLF departments.

The core task of the Drug Product department is the filling of the (end) product in vails, package the vails and transport the product. We use different techniques to carry out the entire process. You will work under extremely high GMP standards. Equipment will be used in isolators and the filling process will be an automatic process with a robot.

Responsibilities & impact that YOU have: 

The core tasks of a Senior Manufacturing Operator DP consist of:

• Cooperating in the execution of the core tasks and the supporting, routine activities of the department . These core tasks are performed according safety guidelines and a detailed work instruction, after which the completed process actions are immediately noted in the relevant documentation (batch record) and computer systems.
• Monitoring progress and checking whether the activities are being carried out correctly:
• Is the point of contact for production-related questions within the team.
• Signals deviations (gaps), resolves them correctly and preventively.
• Takes the initiative to solve problems, where possible yourself and otherwise in close cooperation with the Manufacturing Supervisor and/or manufacturing specialist/process engineer.
• Replaces the Manufacturing Supervisor in the absence of process related tasks.
• Responsible for preparing the training schedule and ensuring that appropriate training is given to manufacturing operators in existing and new processes and technologies.
• Responsible for continuous improvement of work processes and procedures.

With your specific drug product knowledge you will contributing to continuous improvements of work processes and procedures and participating in projects.

• Signals structural shortcomings and opportunities for improvement. You are involved or coordinate improvement initiatives (CI) that are practical in nature and do not require support from other departments.
• You are responsible for (co-)developing work processes and procedures in consultation with manufacturing specialists/process engineers.
• Proactive role in department improvement initiatives (BI/CI improvements) and participates in the initiation phase of QIs and is involved in deviation investigation and follow up.
• Participation in Projects 
• Contributes information and ideas in departmental and project meetings. 
• Is a project team member and/or is consulted by team members to realize project goals. 
• Support implementation of new equipment, process, and procedures 
• During the preparation phase (the transfer of new products to the VLF per 2024), you will be contributing to the realization of the production possibilities in our factory the coming years.