QA Computer System Validation Engineer CAR-T in Beerse, Belgium

• This fulltime position will be based at our Beerse and Ghent sites in Belgium. You will divide your time between the two sites for 3 days per week as part of our J&J flex model.

Change lives for the better.

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/.

THE OPPORTUNITY

You have a passion for Quality, love well-functioning systems and you are eager to gain in-depth knowledge of the quality & compliance requirements in this field? Then this position is waiting for you!

We as QA CSV group belong to the Quality organization of Janssen Supply Chain and are responsible to ensure the quality and compliance of different systems on the J&J Belgian Campus (including commercial and clinical activities in Beerse, Olen, Geel and Ghent).

To strengthen this team, we are looking for a Quality Assurance Computer Validation Engineer (M/F/X), located in Beerse and Ghent Belgium, with focus on CAR-T Ghent systems. The function will allow up to 2 days per week work at home.

The responsibilities & impact YOU will have:

• 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

The responsibilities & impact YOU will have:

• 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.

We would love to hear from YOU, if you have the following essential requirements:

To be successful, you demonstrate the ability to communicate effectively at all levels within a virtual matrix environment. Further requirements include:

• Master scientific degree or equivalent experience.

• 5 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.

Closing date: Friday, 29th of November 2024.

Being part of Johnson & Johnson can change everything, including YOU

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 and every 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”!