QA CSV associate CAR-T

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:
Quality

Job Sub Function:
Quality Assurance

Job Category:
Professional

All Job Posting Locations:
Gent, East Flanders, Belgium

Job Description:

The Advanced Therapy Quality team from Johnson & Johnson Innovative Medicine, is recruiting a QA CSV engineer for the CAR-T hub in Europe.

The position will be based in Ghent Belgium.

CAR-T (chimeric antigen receptor T-cell therapy) is a new way to eliminate cancer cells, which work by harnessing the power of a patient’s own immune system.

The patients’ own T cells are harvested and engineered to kill the cancer cells expressing a specific antigen.

To bring this life saving therapy to the patients, Johnson & Johnson Innovative Medicine is looking for new talents to support the QA CSV organisation! So don't hesitate, the patients are waiting!

The QA CSV engineer CAR-T is responsible for providing quality oversight for computer system validation activities in accordance with Janssen policies, standards, procedures, and Global cGMP’s.

Key Responsibilities:



* To assure that all Computer Systems Validation related regulatory requirements are fulfilled during the complete life cycle (concept, project, operational and retirement phase) of computerized systems.


* Act as Process Owner for Computer Systems Validation management.


* Review and approve CSV documents such as SOPs, user requirements, risks analysis’s, Validation Plans, tests, changes, deviations etc…) in order to maintain compliance to regulations, guidelines, J&J policies and standards.


* Maintain a current knowledge of international laws, guidelines and new evolutions related to CSV through courses, conferences, seminars, internal and external benchmarking and literature studies.

Implement this knowledge to maintain and improve Computer Systems Validation at Janssen.


* Prepare for computer system audits and inspections.


* Be the spokesperson for CSV related matters during audits and inspections.


* Perform and follow up on internal and external audits to accomplish regulatory compliance.


* Cooperate with engineering, IT and other teams for the introduction of new systems and processes.


* To give advice and support for the preparation of CSV related activities and guard the cGMP aspects in new projects.

Be a member of multi-functional teams to realize cross-departmental objectives.

Qualifications

Education:


* Master scientific degree or...