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JOB DESCRIPTION:

We are looking for a Manufacturing Process Specialist (Equipment engineer) Fill & Finish to be in Sassenheim, NL, who will strengthen our team of specialists with knowledge and expertise of the filling, labeling and visual examination process and equipment according to Annex 1.
The Lenti Viral Vector (LVV) Facility: Janssen Biologics B.V., part of Johnson & Johnson, has launched a state-of-the-art production facility in Sassenheim. In this new facility lentiviral vectors are produced, which are used in the CAR-T treatments for multiple myeloma and B-cell lymphoma. The Centre of Expertise (CoE) is an essential support group in the LVV Facility.
The CoE is a critical team in the direct support of Operations when it comes to technical process and GMP support. The CoE is key in clear translation of the developed process to a workable process and environment for the shop floor. The CoE always works against the high-quality standards and safety and compliance regulations that are applicable for LVV manufacturing. CoE is responsible for supporting the production teams with specialized and in-depth knowledge and skills in our production processes, GMP (Annex1), Digital Technology, Materials and Single Use Items. The Centre of Expertise (COE) is a team of around 12 specialists, supported by a separate team with GMP specialists.
The CoE team is one of 3 departments within the LVV facility and working with the Operations Department (OPS) which is responsible for the safe, compliant, efficient, and on time production and delivery of the batches (USP, DSP, F&F) and the New Product Introduction (NPI) team to introduce new products or implement big process changes to existing GMP production processes.

REQUIREMENTS/QUALIFICATIONS:

• Bachelor’s degree or equivalent experience in biotechnology, biochemistry, biomedicine, process technology (or equivalent education).
• Manufacturing specialist or Equipment engineer experience in a biotechnology or biopharmaceutical industry environment.
• Proven knowledge in at least one of the following aspects: Annex 1, Drug Product Filling, Visual Inspection.
• Experience with cGMP environment and EHSS standards is required.
• Positive demeanour, proactivity, decisive, and organized with an ability to work individually and in a team.
• Excellent interpersonal skills, written and verbal in English (B2 required) and Dutch (pre)
• Ability to work fulltime in Dayshift

As Manufacturing Process Specialist Fill & Finish you ensure that we meet the unmet needs of today by supporting the operations in making operational processes safer, easier, simpler and more stable. In this role you act as system owner, in which you are the first responsible person to perform acute troubleshooting and support of cGMP batches in the LVV facility. As system owners we enable operations to process first time right with our equipment and guidance. This varies from initial training, writing procedures and instructions till working together in project teams. We enable Operations to excel in production reliability. This includes process documentation, initial training of operations, and qualification of the systems and processes.

Besides this you will be playing a key role in the further development of the Business Unit in terms of new product introduction, efficiency, and reliability. The duties of the Manufacturing Process Specialist Fill & Finish include:

• Manage and use the business processes, with which the equipment performance is analyzed and makes proposals for improvement points with the greatest impact on a specific objective (safety, quality, reliability/efficiency and costs).
• Identify, plan and control changes for system and process robustness (team task allocation and prioritization 0-3 months timeframe);
• Lead/owner business processes and projects that are mainly system or facility related, with peers in service oriented or operating departments.
• Guaranties that the production equipment is in validated state, documentation is up to date, well maintained, and production capacity meets planning.
• Will play a key role in the interaction between our Operation Department on one site and the Maintenance and Engineering teams on the other site.
• Generate 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).
• Initiate and complete test protocols that help to improve the system or process.