Manufacturing Process Specialist

Manufacturing Process Specialist (MPS) – Fill Finish (F&F)

About Johnson&Johnson

At Johnson & Johnson,?we believe health is everything. Our strength in healthcare innovation empowers us to build a?world where complex diseases are prevented, treated, and cured,?where treatments are smarter and less invasive, and?solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

Would you like to be directly involved in supporting a new process that can change people’s life?

Then keep reading!

Project Pollux is the establishment of a new Janssen Supply Chain Lentiviral Vector (LVV) production facility in Sassenheim, the Netherlands to be organized as a new business unit for Janssen Biologics (JBV). This biologic manufacturing facility is intended to become a key supply option for commercial LVV in support of the global J&J Innovative Medicine BCMA CAR-T program for multiple myeloma, a disease affecting ~160,000 patients annually.

Check out where we are located

The production facility is currently being qualified with many milestones in the long-lead project plan.

Are you ready to be part of something groundbreaking? Do you want to make a real impact on patient lives? Are you passionate about innovation and teamwork? Then, we want you!

Janssen Biologics is recruiting a Manufacturing Process Specialist F&F to join our Operational Readiness team. You will play a crucial role in supporting this new facility now and in the future.

Shift Operations organization

In full operation, Shift Operations manufactures the Lenti Viral Vector for our customers. This process is following different steps from cell expansion, virus production and clarification to automated filling and labelling. The process is performed under strict GMP and BSL2 conditions. During the project the team is preparing the plant for operations and supporting the technology transfer from R&D by developing procedures and training, and the team will produce test and qualification batches.

The operation department is divided into three principal areas: The Upstream Processing (USP), Downstream Processing (DSP) and Fill & Finish Processing Department (F&F). The USP department is about the culturing of cells, transfection, and clarification. The DSP department purifies the product using various techniques, partially in aseptic process. The F&F department fills vials with the final product, then vials are visually examined and automatically labelled.

Job Summary:

The Fill & Finish department (F&F) purifies, fills and visual examines the product using various techniques.

During the project phase you will work on the technology transfer from R&D to manufacturing. You will participate manufacturing readiness initiatives of new equipment and processes. This includes process documentation, training, and qualification.

As soon as the facility is in operation you will further develop the manufacturing process to achieve a stable and reliable operation. You will develop site performance management tools, facilitate investigations and develop safety and compliance follow ups (CAPA).

Besides this you will be playing a key role in the further development of the Business Unit in terms of capacity, new product introduction and efficiency.

The responsibilities and the impact YOU will have:

As a Manufacturing Process Specialist you are responsible for keeping, monitoring and improving processes and equipment in good condition within the framework of EHS&S, GMP and MPS:

• Is a member of the Operations Readiness Team during the start-up phase of the facility.
• Is a knowledge carrier.
• Facilitates process and equipment improvements. This also includes leading and carrying out the Change Control process and defining the User Requirements in consultation with other parties.
• Actively leads and participates in root cause investigations, identification of corrective and preventive actions and ensures that these are taken care of adequately and within agreed timelines.
• Runs projects related to production capacity and equipment life cycle management.
• Initiates and leads improvements in the field of ARBO/EHS and quality.
• Uses data and modelling as tools for preventing process deviations or process improvements.

We would love to hear from YOU, if you have the following essential requirements:

Capabilities identified as priority for our Workforce of the Future are:

• Digital & Technology
• Change Leadership
• Critical Thinking & Problem Solving
• Process knowledge & expertise
• End to End mindset

CGMP, EHS&S, EN LEAN

The work is carried out under strict cGMP conditions. The operator ensures a safe, healthy and sustainable working environment. The execution of tasks, the organization of the work and the continuous improvement of efficiency, effectiveness, quality and cGMP and EHSS compliance are supported by Lean techniques and concepts. The MPS has good knowledge of cGMP, EHSS and Lean, at the level appropriate for this position, is trained in the internal procedures and always follows these, as well as other internal standards. The MPS identifies shortcomings and opportunities for improvement. He/she occasionally carries out improvement initiatives that are practical in nature and do not require support from other departments.