CSV Engineer

CSV Engineer 

Location: Ghent Or Beerse hybrid working 

Hours: 40 hrs- Until Dec 31st (possible extension)

Essential:  3 years plus CSV, quality, GMP environment, pharma experience, fluent in English 

The Department: 

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 Role:

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.

Benefits

This role offers a competitive hourly rate & a supportive working environment. 

About Johnson & Johnson MedTech

At Johnson & Johnson MedTech, we unleash diverse healthcare expertise, purposeful technology, and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible.

For more than a century, we have driven breakthrough scientific innovation to address unmet needs and reimagine health. In surgery, orthopaedics, vision, and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalised.

https://www.jnj.com/healthcare-products/medtech

application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. Please apply via the link.

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.