QA CSV and Data Integrity expect

At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.

We provide an inclusive work environment where each person is considered as an individual.

At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:
Quality

Job Sub Function:
Quality Assurance

Job Category:
Professional

All Job Posting Locations:
Beerse, Antwerp, Belgium, Gent, East Flanders, Belgium

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements.

Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine The Advanced Therapy Quality team from Johnson & Johnson Innovative Medicine, is recruiting a QA CSV engineer and Data Integrity expert for the CAR-T hub in Europe.

The position will be based in Ghent or Beerse Belgium.

The QA CSV engineer and data integrity expert is responsible for providing quality oversight in accordance with Janssen policies, standards, procedures, and Global cGMP's for computer system validation and data integrity in manufacturing and lab area'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.
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