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

Job Function:

Job Sub Function:

Job Category:

All Job Posting Locations:

Job Description:

Johnson and Johnson Innovative Medicine is recruiting a Quality Assurance Project Engineer who will focus on ensuring the quality of our MES (Manufacturing Execution Systems) projects for the CAR-T hub in Europe. The position will be based in Ghent Belgium.

CAR-T (chimeric antigen receptor T-cell therapy) is an innovative approach to eliminate cancer cells, which work by harnessing the power of a patient’s own immune system. They are created from the patients’ own T cells and are engineered to eliminate cancer cells expressing a specific antigen.

To support the CAR-T program in EMEA, Janssen has built two CAR-T manufacturing centers in the Ghent area (Belgium). The QC laboratories are in the existing Janssen Beerse site.

The QA Project Engineer MES, CAR-T Europe makes part of the MES automation team at the CAR-T sites in Ghent. The CAR-T site in Ghent is a fast-growing facility at the forefront of innovative technology. Our MES team is owning the lean initiative to develop a paperless office which includes the development of standards and procedures for implementation.

As a new dynamic team, we strive for continuous improvement every day. Being in the foundational stages we have the unique opportunity to shape and create the best path forward.

You will be involved in interaction with multiple departments, involved in new automation projects and initiatives, allowing you to learn and contribute to enhance the processes to bring CAR-T to our patients. You will collaborate with colleagues who may be in different countries, encouraging an international work environment. We are goal-oriented, and while we value getting the job done, you will also have the flexibility to work from home or in the office as needed.

You will be responsible for:

• Collaborate with the production and engineering teams to elevate the automation level by transforming paper-based documentation into electronic master batch records.
• Lead QA activities in MES projects including required validation execution and documentation
• Provide quality assurance (QA) support to the MES CAR-T project team, ensuring the project meets customer specifications
• Collaborate with project managers, developers and manufacturing teams to align on the quality and compliance requirements for MES applications
• Review validation documentation including PQ protocols, tests, traceability matrices
• Ensure MES solutions align with GMP and other regulatory standards
• Conduct risk assessments, deviation management and change control reviews
• Participate in and support audits and internal quality reviews
• Act as an expert resource in assessing and maintain quality and compliance standards, including providing guidance and training to ensure adherence to regulatory requirements and standards
• Possess the ability to grow as a yellow or green belt specialist in lean automation projects
• Establish and maintain effective working relationships with the different business partner and Legend Biotech to ensure alignment of objectives and deliverables
• Ensure the quality oversight of the operational activities by documented QA approval of GMP documentation and support in the different quality review meetings
• Active participation in project teams, operational teams & system teams
• Close collaboration with operations, IT & automation

Qualification & Requirements:

• Bio-Engineer, (Industrial) Pharmacist or a bachelor’s or master’s degree in a technical field (e.g., Engineering, Computer Science, etc.) with at least 2 years cross functional experience in pharmaceutical industry.
• Up-to-date knowledge and in-depth understanding of relevant pharmaceutical legislation related to cGMP regulations.
• Strong analytical thinking and decision-making skills.
• Experience with master batch records and/ or quality assurance in production environments is required
• Experience with MES systems in production environments is a strong advantage
• Strong interpersonal skills and a solution-oriented attitude
• Ability to work independently as well as in a team setting.#RPOAMS