QA CSV associate CAR-T

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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.

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CAR-T (chimeric antigen receptor T-cell therapy) is a new way to eliminate cancer cells which work by harnessing the power of a patients 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 dont 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 cGMPs.

We are searching for the best talent for a QA CSV engineer for the CAR-T hub in Europe based in Ghent Belgium.

You are responsible for:

• 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 analysiss 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.

Qualification / Requirements:

Education:

• Master scientific degree or equivalent experience.

• 3 years experience in the pharmaceutical industry.

• Knowledge of cGMP/CSV compliance (21 CFR Parts; 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 want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear fair and respectful of your time.

Heres what you can expect:

• Application review: Well carefully review your CV to see how your skills and experience align with the role.
• Getting to know you: If theres a good match youll be invited to a short call with one of our recruitment team to understand more about you and answer any questions that you might have.
• Staying informed: We know waiting can be hard and processes can evolve; our recruitment team will keep you updated and make sure you know what to expect at each step.
• Final steps: For successful candidates you will need to complete country-specific checks before starting your new role. We will help guide you through these.

Required Skills:

Preferred Skills: