QA CAR-T Qualification Lead EMEA

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
Supply Chain Engineering

Job Sub Function:
Quality Engineering

Job Category:
Scientific/Technology

All Job Posting Locations:
Gent, East Flanders, Belgium

Job Description:

Johnson & Johnson Innovative Medicine is recruiting a CAR-T QA C&Q Lead 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, J&J started up two CAR-T manufacturing centers in the Ghent area (Belgium).

The QC laboratories are operated from the existing J&J Beerse site.

As the CAR-T Qualification lead, you will play a pivotal role in ensuring the qualification of critical systems, equipment, facilities and utilities used in CAR-T Manufacturing.  You will lead a team of QA C&Q engineers and collaborate cross functionally with engineering, maintenance, validation, and operation teams to ensure all systems and processes meet global GMP and regulatory expectations.
 

Job Responsibilities:


* Lead a team of CAR-T QA Qualification Engineers and coordinate all QA Qualification activities related to qualification (IQ/OQ/PQ) of equipment, facilities and utilities.


* Review and approve qualification documents such as change controls, master documents, protocols, reports, rationales, SOP’s, URS, IA, & QSR’s and related GMP documentation such as calibration rationales, calibration master forms and completed calibration records, master data set-up, maintenance plans.


* Review and approval of data integrity deliverables such as system audit trail and user access reviews.


* 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


* Ensure risk assessments (e.g.

FMEA, …) are appropriately conducted and documented.


* Serve as QA representative during internal and external audits and regulatory inspections.


* Support the implementation and continuous improvement of SOP’s and work instructions related to qualification.


* Collaborate cross functionally with the MAM (make asset management) and E&PS (engineering and pro...