CAR-T QA C&Q Engineer

CAR-T QA C&Q Engineer

• Location: Beerse (Hybrid)

• Duration of the contract: 31 December 2026 (Possibility to extend)

• Hours per week: 40

Imagine your next project supporting the fight against cancer by ensuring the highest quality standards for groundbreaking CAR-T cell therapy.

As a CAR-T QA C&Q Engineer, you will join our dedicated QA Qualification Team. You will play a pivotal role in guaranteeing that our innovative manufacturing centers meet strict global regulations by guarding the qualification status of critical production assets for our facilities.

roles and responsibilities 

As the QA process expert, you will act as a vital link between Quality, Engineering, and Manufacturing.

This will involve:

• Working closely together with the MAM (make asset management) and E&PS department and guarding the qualification status of critical production assets by ensuring that all system critical aspects related to facilities & utilities, product and process requirements are identified, qualified and controlled by a mitigation plan.

• Ensuring that deviations related to equipment issues with possible impact on quality and/or compliance are evaluated, thoroughly investigated and that adequate corrective and/or preventive actions are defined and implemented.

• Working closely together with the manufacturing department to approve new change controls.

• Building a strong connect with different quality organizations.

• Managing the compliance status of critical production (make) assets by means of review and approval of procedures (e.g., calibration rationales, master forms, master data set-up, maintenance plans) and following up on data integrity deliverables such as system audit trails and user access reviews.

• Participating in the preparation for regulatory and customer inspections and acting as a spokesperson for QA qualification.

• Approving qualification documents (change controls, master documents, protocols, reports, rationales, SOP’s, URS, IA, QSR, etc.) including discrepancies/events/non-conforming situations and related corrective actions occurring during execution of qualification activities.

• Participating in system and process improvement/optimization projects and assuring quality and compliance aspects while maintaining a current knowledge of international regulations, guidelines, and industry practices.

how to succeed 

We are looking for a highly analytical and communicative professional who sees it as a challenge to defend our strategy and documents toward health authority inspections.

You will also bring:

• Master’s degree in engineering with chemistry or analytical background or in pharmaceutical sciences

• Thorough knowledge of Dutch and English, both orally and in writing

• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell therapy products

• Awareness of quality and the ability to apply strong communication skills to work cross-departmentally in a continuously changing environment.

• Affinity with computerized systems, system parameter configurations, and data management in critical production assets.

• Strong analytical thinking, risk assessment, collaboration, and teaming skills.

benefits 

This role offers a very competitive hourly rate. This contract will run until 31 december 2026 (Possibility to extend).

you are welcome here 

Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about Johnson & Johnson Innovative Medicine 

Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow. Our diverse portfolio spans multiple therapeutic areas — Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina. We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way.

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.

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”.