QA - CSV Specialist & Site Key User

QA - CSV Specialist & Site Key User

• Location: Beerse

• Duration of the contract: Until Dec 31, 2027

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

Imagine your next project driving the digital transformation of execution systems in a cutting-edge GxP manufacturing environment. This combined role supports two complementary areas. Approximately 50% of the assignment provides independent QA-CSV oversight and practical validation support for execution systems used in GxP manufacturing. The remaining 50% acts as Site Key User for Checklyst Manager, a core digitalization system used to transition paper checklists and calculation files into controlled digital workflows.

roles and responsibilities 

You will provide vital QA-CSV support and system governance to ensure our digital manufacturing systems remain compliant, efficient, and secure.

This will involve:

• Providing QA-CSV support across projects, changes, operation, periodic review, and retirement for PLC/SCADA systems, environmental monitoring, and Automation Network Shared Services.

• Reviewing and approving validation deliverables, including assessments, plans, requirements, risk assessments, specifications, test documentation, and summary reports.

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

• Applying a pragmatic, risk-based approach focused on critical functions, data, interfaces, and controls (access management, audit trails, backup, etc.).

• Coordinating and overseeing the proper creation, configuration, testing, and documentation of new digital checklysts.

• Onboarding new areas and teams, including alignment on intended use, responsibilities, training, and readiness for adoption.

• Providing first-line functional guidance to users, governing user access, and coordinating escalation of system issues.

• Running and reviewing system and process metrics, ensuring records are under control and closed within acceptable timelines.

how to succeed 

To be successful in this role, you will need a strong background in computer systems validation and a knack for digital system governance.

You will also bring:

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

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

• 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.

• Fluent English.

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

• Ability to translate business processes and paper-based activities into clear, controlled digital workflows and checklists.

• Experience supporting system users, coordinating stakeholders or acting in a key-user, application-support or system-governance role.

• Dutch is an advantage for local stakeholder interaction.

• Preferred experience with PLC/SCADA, industrial automation networks, Active Directory, SIMATIC Logon, backup/restore, or digital checklist solutions.

benefits 

This role offers a very competitive hourly rate. This contract will run until Dec 31, 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 

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. As a skilled contractor, you’ll play a key part in the thinking, strategy, dynamism - and impact - of this iconic global healthcare company as they touch the lives of nearly a billion people every day. Contribute to the next healthcare breakthrough with your next project at Johnson & Johnson.

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”.