Quality Project Engineer

QA Project Engineer Documentation  MES / CAR-T

Location: Beerse

Hours: 40 hrs - hybrid working 

Start Date: Asap - contract role until 31st Dec (possible extension)

Essential:  English & Dutch

The Department: 

Johnson and Johnson Innovative Medicine is recruiting a PQ/GO Live Document Support Engineer MES, 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 Beerse 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.

The Role:

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, supporting the CAR-T sites in Ghent & Beerse. 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.

Job Duties and 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 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 communication skills and a solution-oriented attitude

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

Benefits

This role offers a competitive hourly rate & a supportive working environment. 

About Johnson & Johnson MedTech

At Johnson & Johnson MedTech, we unleash diverse healthcare expertise, purposeful technology, and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible.

For more than a century, we have driven breakthrough scientific innovation to address unmet needs and reimagine health. In surgery, orthopaedics, vision, and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalised.

https://www.jnj.com/healthcare-products/medtech

application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. Please apply via the link.

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.