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Job Description:

Are you inspired to make a big difference in the life expectancy of our patients ?

CAR-T is an innovative treatment, which uses the power of the patient’s own immune system. A patient’s T-cells are genetically modified to eliminate cancer cells. This ground-breaking, innovative technology provides hopeful prospects to patients where other therapies have failed or fail to provide adequate results.

Janssen Biotech, Inc. entered into a global collaboration agreement with Legend Biotech to develop, manufacture and commercialize ciltacabtagene autoleucel (cilta-cel). Through our strategic partnership, we look to advance the promise of an immunotherapy in the treatment of multiple myeloma.

To support the Autologous CAR-T program in EMEA, Janssen is building a CAR-T supply chain in Belgium (Ghent and Beerse).

The Production Support Engineer is part of the Operations Team. The position supports readiness and helps to ensure daily supporting operational activities, while also contributing to safety, quality, compliance, delivery and cost-effectiveness for clinical and commercial cell therapy production across the Ghent sites and Beerse. The function works in close connection with the Cell Processing Engineers, Operations, Finance, Procurement, Quality, MSAT, Make Asset Management, Vein-to-Vein Planning and Tech Transfer Teams.

This position will be based at our two new manufacturing facilities (Obelisc & Tech Lane) in the leading Biotechnology Hub of Ghent, Belgium. You will have the unique opportunity to gain deep knowledge & expertise in a highly innovative and future oriented environment with the ability to profoundly impact the trajectory of health of our patients.

Roles & responsibilities:

As the Production Support Engineer, you hold a pivotal role in the design, maintenance, and continuous improvement of well-defined operational support activities within manufacturing. These activities encompass, but are not limited to:

• Pre-Processing activities like sterilization (internal and external) and kitting (internal and external)
• Non-Cell Processing Related Materials (a.o. consumables, artwork, gowning)
• Site Risk Assessment Management
• Access Rights Management
• Order Management

In a dynamic and fast-paced environment, you play a central role in the organization. By collaborating with various other functions you will support the successful transfer of the CAR-T process, the timely start of clinical and commercial manufacturing and further improvement and scale-up of the process.

You take ownership of and will handle all related requirements, including the following responsibilities:

• Liaison between Ghent operations and pre-processing activities (sterilization and kitting), facilitating communication, resolving issues, optimizing processes, and ensuring seamless collaboration to enhance overall production efficiency.

• Lead, as operations SME, business review meetings with external partners. Present performance data, identify issues, propose action plans, and ensure accountability for continuous improvement and operational execution.

• Demonstrate strong business acumen and financial knowledge to ensure the operational activities align with organizational goals and financial objectives.

• Drive continuous improvement. Regularly track and analyze key performance indicators (KPIs) to assess production efficiency, material usage (scrap and yield), quality (NCs) and delivery (OOS, lead times). Oversight CAR-T materials, incl. kit composition, unit labeling, … Work closely together with MSAT material scientist and QA material SME to identify and execute continuous improvement project to reduce the scrap rate and material defects

• Develop, review and approve robust operational documentation framework of the operational supporting activities, including operating procedures, work instructions etc., and ensure adequate training of the organization. Perform operational assessment for changes.

• Participate in the Change Control/Technical Board, Quality Improvement Plan (QIP)

meetings and in Operational Performance Review meetings with focus on continuous

improvement of the operational supporting activities. Contribute to root cause investigations and develop, review, approve (and own) robust CAPA plans.

• Site Risk Assessment Management: Own and facilitate site risk management processes with impact on operations.

• Access Rights Management: Control and monitor user access to operations areas and systems to ensure security and compliance.

• Order management: oversee customer orders of operations from placement to fulfillment.

• Act as a spokesperson for your area during health care inspections.

• Building a network within Johnson & Johnson business, quality, safety and other

departments and with partner Legend Biotech to ensure that all quality, compliance and

safety requirements can be met.

• Instill a mindset of high standards of safety and cGMP compliance, ensuring the reliability of your operations and readiness for audits or inspections at all times.

Experience

Minimum 5 years of relevant work experience, preferably in aseptic manufacturing.

Qualification & skills

• You have a Master’s Degree in a scientific or technical field (Engineering, Bioscience Engineering, Industrial Engineering, Pharmacy, Biochemistry …).
• You place our patients at the center of everything you do.
• You embrace diversity, equity, and inclusion.
• You have strong knowledge of aseptic manufacturing.
• You have detailed knowledge of the shop floor manufacturing process.
• You have a start-up/can-do mindset, and you proactively search for solutions.
• You prioritize, and provide clear instructions to peers.
• You thrive in a rapidly changing environment and lead as a change agent to promote flexibility, creativity, and accountability while at the same time handling procedures/guidelines which require strict execution.
• Your verbal and written communication skills enable you to influence without authority.
• You work independently and successfully, prioritizing and managing multiple tasks simultaneously, and integrating cross-functional issues.
• You are able to concisely summarize and present results.
• Experience with team-based collaborations is a must.
• Experience with analyzing financial/supply chain processes, understanding key metrics, and evaluating financial/supply chain performance is an asset.

Our offer

• The opportunity to participate in a progressive treatment that gives hope to patients in need.
• The ability to help shape a new venture from the start.
• An innovative working environment.
• Training on the job for this specific treatment.
• Opportunities to continue to develop and grow in an extensive and strong organization.
• An open-ended contract and a competitive remuneration package.
• Opportunities to continue to develop and grow in an extensive and strong organization.
• An open-ended contract and a competitive remuneration package.