BE - Engineer 3, Quality Engineering

CAR-T is an innovative treatment, which uses the power of the patient’s own immune system. A patient’s T-cells are genetically modified to eliminate cancer cells. This ground-breaking technology provides hopeful prospects to patients where other therapies have failed or fail to provide adequate results.

To support the CAR-T program in EMEA, Janssen is building two CAR-T manufacturing centers in the Ghent area (Belgium).

As Quality Engineer you will be able to work hybrid and requirs to go on-site in Beerse and Ghent.

Your responsibilities and your Impact:

• Supports the C&Q group in providing documented evidence that all equipment and utilities used in/by/for JSC are qualified and remain in a state of control so that they deliver processes and products that comply to regulatory and business specifications

• Is responsible for the coordination of qualification activities assigned to him/her

• Is responsible for technical content of Equipment Qualification files assigned to him/her

• Acts as a Technical Owner within JSC CAR-T Organisation

• Technical and function specific tasks and responsibilities

• Provides business support as technical owner (questions, technical issues), when requested

• Makes detailed assessments for the projects, changes, modifications, good practices, corrections, remediations, break-downs, non-compliance issues, investigations etc assigned to him/her by the C&Q lead.

• Passes on requests made to C&Q team to C&Q lead · Takes part in the core team / planning meetings of projects, etc assigned to him/her by the C&Q lead

• Keeps status of projects, etc assigned to him/her by the C&Q lead · Asks for support or information from C&Q lead when needed. Involves C&Q lead for escalation when needed · Enters assessments and completed tasks in Trackwise

• Communicates with the involved departments regarding test planning, test materials, resources, etc for projects, etc assigned to him/her

• Supports in the evaluation of project issues and changes towards impact on approach of qualification activities (f.e. deviations from protocol, scope changes)

• Ensure qualification activities are performed in a qualitative and timely manner (within reasonable expectations)

• Reviews and approves qualification documents written by other C&Q engineers (URS, SRS, IA, DQ, QP, IQ, OQ, discrepancies, PQ, QSR, VMP, PSQR)

• Works together with the QA qualification team to get qualification files approved · Reviews the executed qualification tests documented by other C&Q engineers or other testers

• Initiates and follows-up QI?s and corrections in Trackwise when needed for projects, changes, etc assigned to him/her by the C&Q lead

• Own and manages C&Q processes together with other C&Q engineers and the C&Q lead (aVMP, Periodic reviews, change evaluation, L4L evaluation, qualification etc?)

• Contributes to C&Q team internal improvement projects

• Support during internal and external inspections

Quality and Compliance responsibilities:

• Acts compliant with GMP requirements

• Based on expertise, maintains a current knowledge of international regulations, guidelines and industry practices related to system (process equipment) qualification

• Based on expertise, identifies gaps in procedures, qualification files or existing systems and alerting C&Q lead.

• Strives for high quality equipment qualification files

• Identifies quality catches and Kaizen opportunities and reports them to C&Q lead

• Strives to complete all mandatory trainings within their due date

Education and Experience Required for Role:

• 5yrs or more

• Engineering and possibly in the life science (but not must)

• Dutch and/or English

• Location Beerse and Gent

• Open perspective:

• Can simplify problems, go to the basis of our problems and find solutions there

• Want to learn new things

Things to remember before applying for this role:

• We do not accept applications via email.

If you are interested in this role please apply now! Make sure you fill out your application in full, your personal CV will be used for the recruiter’s reference only, they are not sent to Hiring Managers. Ensure all relevant information is included in your application! 

Thank you very much and we look forward to receiving your application.

Questions

If you would like some additional information about the role please contact: bdardenn@its.jnj.com (please note that 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 in Belgium 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”.