Johnson and Johnson

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 equivalent experience.
• 3 years’ experience in the pharmaceutical industry.
• Knowledge of cGMP/CSV compliance (21 CFR Parts 11, 210, 211; EU Directive 2003/94/EC and annex 11; GAMP, Data Integrity Guidelines)
• Experience with Computerized System Validation.
• Strong ownership and quality attitude. You are able to deliver on commitment timelines.
• Ability to make risk-based decisions. Understands the business implications regarding quality positions and decisions.
• Fluent in verbal and written communication in English and Dutch and are able to connect with diverse partners.

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through ground breaking programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.]

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.