Commissioning and Qualification Engineer

CAR-T QA C&Q Engineer

Location: Gent

Working mode: Hybrid (Fully on-site during busy periods)

Duration: Contract running until the end of 2025 (opportunity for a contract extension)

Language requirements: Dutch and English

Hours: 40 hours per week

Pay rate range: Competitive hourly rate

The Janssen Supply Chain Group, a member of the Johnson & Johnson family of companies, is recruiting a CAR-T QA C&Q Engineer for the CAR-T hub in Europe.

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 is starting up two CAR-T manufacturing centres in the Ghent area (Belgium). The QC laboratories will be operated from the existing Janssen Beerse site.

The CAR-T QA C&Q Engineer is part of the CAR-T QA Qualification Team in Ghent. He/she will be responsible for review and approval of qualification and requalification activities, related to Facilities and Utilities (F&U) and Process Equipment at the Janssen/Legend Biotech facilities in Ghent.

roles and responsibilities

• Will work closely together with the MAM (make asset management) and E&PS department and guard 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 and ensure 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

• Will work closely together with the manufacturing department to approve new change controls and to ensure that deviations with possible impact on quality and/or compliance are evaluated, thoroughly investigated and that adequate corrective and/or preventive actions are defined and implemented 

• Will build a strong connect with different quality organizations

• Will manage the compliance status of critical production (make) assets by means of review and approval of procedures e.g. calibration rationales, calibration master forms and completed calibration records, master data set-up, maintenance plans and follow up daily operations activities by review and approval of data integrity deliverables such as system audit trail and user access reviews

• Approves 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 (correction, CPA) occurring during execution of qualification activities.

• Participates in system and process improvement / optimization projects and assure quality and compliance aspects and maintain a current knowledge of international regulations, guidelines and industry practices and become the QA process expert.

how to succeed

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

• awareness of quality; have knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell therapy products and you see it as a challenge to defend our strategy and documents towards health authority inspections.

• affinity with computerized systems, System parameter configurations and data management in critical production assets

• ability to show and apply strong communication skills and are known as a great teammate who can work cross departmental in a continuous changing environment

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

• Strong analytical thinking, risk assessment and communication skills

• Collaboration and teaming skills

benefits

This role offers a very competitive hourly rate. This contract will run until the end of 2025 and has a strong chance of extension. 

you are welcome here

Johnson & Johnson Innovative Medicine 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. The pay rate for this role will depend on how you are paid. Options are available. 

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”.