QA CSV Engineer

QA CSV Engineer

Location: Beerse, hybrid working - 3 days a week on site

Duration: Until December 2026

Hours: Full-time / 40 hours

Imagine your next project contributing to the cutting-edge of personalized medicine as a QA CSV Engineer for Car-T computerized systems, ensuring regulatory excellence at an iconic global healthcare company.

roles and responsibilities.

• To assure that all CSV related regulatory requirements are fulfilled during the complete life cycle (concept, project, operational and retirement phase) for Car-T computerized systems.

• Review of trends within the CSV (including cGMP) area and initiation of actions/improvements.

• Act as a mediator between the various involved groups regarding CSV.

• Act as Process owner for computer systems validation management (local applications)

• Maintain the Validation Master Plans up-to-date and ensure timely execution.

• Review and approve CSV documents such as SOPs, user requirements, impact/risks analysis, Validation Plans, tests, etc in order to maintain compliance to regulations, guidelines, J&J policies and standards.

• Be part of IT / engineering teams and interact with other groups 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 cross-functional teams to realize cross-departmental objectives.

• Be involved in Change Management.

• Address and follow-up of deviations occurred during execution of qualification/validation activities.

• Evaluate the incidents related to CS and propose corrective/preventive actions if necessary. Identify possible impact on the product quality and pass the incident to QA focus if this is the case.

• Provide periodic reports on quality system compliance (metrics).

• Prepare for system audits and inspections.

• Be the spokesperson for CSV related matters during audits and inspections.

• Follow-up activities related to CSV resulting from (internal and external) audits, quality system initiatives (FIR, CAPA, QIP, etc), MAP, etc.

• Perform internal and supplier audits and guide auditee(s) to accomplish regulatory compliance.

• Be the CSV and Part11 expert within Car-T.

• Maintain a current knowledge of international regulations, 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 Computerized Systems Validation at J&J Car-T.

• Prepare training material on regulatory CSV topics and train persons from Car-T organization.

• Stimulate innovative behaviour of the employees.

• Find and implement ways to keep knowledge and expertise in-house.

• Always respect our credo values

how to succeed.

• Knowledge of cGMPs: 21CFR11, 21CFR210, 21CFR211, Directives 75/319/EEC and 2003/94/EC Volume 4 and annex 11 and related GMP Guidelines and Preambles.

• Knowledge of GAMPs: generic and specific (Global Information Systems, IT Infrastructure Control and Compliance, A Risk-Based Approach to Compliant Electronic Records and Signatures, Validation of Laboratory Computerized Systems, Testing of GXP System).

• Knowledge of SW development and testing processes.

• Knowledge of Quality auditing

• Knowledge of Software quality metrics

• Capacity to "translate" technical information into information that can be understood at every level of the organization.

• Being able to correctly estimate the urgency, criticality and impact of decisions related to the function.

• Ability to multi-task and work on a variety of projects at one time.

• Ability to work independently and work in cross-functional team environment.

• Good communication skills.

• Good project management skills.

• Good problem solving skills.

• University degree or similar

• Fluent in English (written and spoken)

• Fluent in Dutch

• Quality Management System

• IT systems used within pharmaceutical and chemical manufacturing: PLCs, MES, LIMS, warehouse management systems, monitoring systems etc.

• Deviation and Change Management Systems. (e.g. IRIS, Comet)

• Document Management Systems (e.g. TruVault, Asset Management)

• Training Management Systems (e.g. Summit)

• Microsoft OS, networks, virus protection

• Test Tools (e.g. qTest, KNEAT)

benefits.

This role offers a very competitive hourly rate.

This contract will run for Until December 2026

you are welcome here.

Johnson & Johnson is 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.

about Johnson & Johnson Innovative Medicine

Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow. Our diverse portfolio spans multiple therapeutic areas — Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina. We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way.

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.

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”.