QA - CSV Specialist

QA-CSV Specialist

• Location: Beerse, Belgium

• Duration of the contract: Until 31 December 2027

• Hours per week: 40 per week | Contract: Fixed-term Employee Payroll only (No B2B / No Freelancers)

Imagine your next project working alongside industry leaders to elevate the standards of healthcare innovation. We are looking for a focused and experienced QA-CSV Specialist to join our team in Beerse. In this role, you will provide critical quality oversight and ensure that our execution systems for GxP manufacturing are both efficient and rigorously compliant.

roles and responsibilities 

You will play a crucial role in maintaining the validated state of our systems and supporting the lifecycle management of our critical manufacturing technology.

This will involve:

• Provide QA-CSV support throughout the system lifecycle, including projects, changes, operation, periodic review and retirement.

• Review and approve validation deliverables such as impact and compliance assessments, validation plans, requirements, risk assessments, specifications, test documentation, traceability and summary reports.

• Assess changes, incidents, deviations, defects and CAPAs for impact on product quality, patient safety, data integrity and the validated state.

• Apply and promote a pragmatic, risk-based validation approach focused on critical functions, data, interfaces and controls.

• Assess data integrity controls for access management, audit trails, electronic records and signatures, time synchronization, backup, restore, retention and data transfer.

• Support data-flow mapping and clarify system boundaries, interfaces, critical records, metadata and control ownership.

• Support periodic reviews, inspection readiness and audit or inspection questions for assigned systems.

• Communicate quality risks clearly, challenge constructively and escalate material compliance concerns when required.

how to succeed 

To thrive in this role, you should have a solid foundation in computer systems validation and a pragmatic approach to problem-solving.

You will also bring:

• Bachelor or Master degree in Engineering, Automation, Computer Science, Life Sciences or a comparable technical or scientific discipline.

• Typically 4-7 years of relevant experience in CSV, validation, quality assurance, automation or computerized systems within a GxP-regulated environment.

• Practical experience with lifecycle documentation, testing, change control, deviation management and maintenance of the validated state.

• Experience with manufacturing, monitoring, automation or infrastructure-related computerized systems.

• Good working knowledge of CSV, SDLC, EU GMP Annex 11, US FDA 21 CFR Part 11, GAMP 5 and recognized data integrity expectations, including PIC/S guidance.

• Understanding of risk-based validation, electronic records and signatures, access controls, audit trails, backup and restore, interfaces and supplier documentation.

• Ability to understand technical system architecture and translate it into clear validation and quality decisions.

• Effective communication, collaboration and organization skills, with the confidence to challenge while maintaining a solution-oriented approach.

• Fluent English; Dutch is an advantage for local stakeholder interaction.

• PLC/SCADA, industrial automation networks, shop-floor systems or particle monitoring solutions.

• Active Directory, group policies, SIMATIC Logon, patching, antivirus, backup and restore, monitoring or file-transfer services.

• Data-flow mapping, data integrity risk assessments, periodic reviews or inspection support.

benefits 

This role offers a very competitive hourly rate. This contract will run until 31 December 2027.

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”.