QA Project Engineer MES, CAR-T Europe

About Innovative Medicine

Ourexpertisein Innovative Medicine is informed and inspired by patients whose insights fuel our science-based advancements.Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments finding cures and pioneering the path from lab to life while championing patients every step of the way.

Learn more at 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 patients 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 leading 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 fostering 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.

Major Responsibilities:

Project and Operational Quality Performance:

• 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 comply 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

Experience and Skills:

• Bio-Engineer (Industrial) Pharmacist or a bachelors or masters 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 communication skills and a solution-oriented attitude

• Ability to work independently as well as in a team setting.

At Johnson & Johnson we want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear fair and respectful of your time.

Heres what you can expect:

• Application review: Well carefully review your CV to see how your skills and experience align with the role.
• Getting to know you: If theres a good match youll be invited to a short call with one of our recruitment team to understand more about you and answer any questions that you might have.
• Staying informed: We know waiting can be hard and processes can evolve; our recruitment team will keep you updated and make sure you know what to expect at each step.
• Final steps: For successful candidates you will need to complete country-specific checks before starting your new role. We will help guide you through these.

Required Skills:

Preferred Skills: