CSV Engineer

As CSV Engineer you will ensure that GMP critical computerised systems are validated, compliant and fit for purpose. You will manage validation activities from documentation to execution and act as subject matter expert in audits, change assessments and troubleshooting.

Validation execution

Develop, implement and execute validation studies for GMP critical computerised systems including URS, SIA, DQ, IQ, OQ, PQ, RV and TM activities.

Documentation

Generate and maintain validation protocols, reports and supporting documentation, ensuring traceability and approval across the lifecycle.

Regulatory compliance

Validate systems in line with GMP, GLP and company procedures, keeping validated status current at all times.

Industry expertise

Stay up to date with evolving FDA and EU requirements, providing technical input on validation testing practices.

Change assessment

Review system changes and assess impact on validated status, ensuring documentation and compliance updates are completed.

Troubleshooting

Investigate and resolve validation related issues, supporting projects and operations to maintain compliance.

Project alignment

Ensure validation activities are managed in line with company and regulatory standards, meeting scope, timing and quality requirements., Our Talent & Business Managers combine a deep understanding of our clients’ needs with a sharp eye for talent. Their focus is on creating meaningful and sustainable matches, always keeping both the role and the candidate in mind.

When a potential match is identified, one of our T&B colleagues may reach out to answer your questions, share additional context about the role and discuss possible next steps together, with clarity and transparency throughout the process.

• Bachelor or Master degree in Sciences, Engineering or a related technical field
• Minimum of 3 years of experience in a GMP pharmaceutical environment
• Strong knowledge of Computer Systems Validation and related methodologies
• Solid understanding of quality and compliance regulations such as GAMP, FDA and EU guidelines
• Experience with validation of software packages and computerised systems
• Ability to troubleshoot validation issues effectively
• Strong communication skills, able to collaborate across teams and stakeholders
• Capable of working independently with a structured and proactive approach
• Fluent in Dutch and English

Pulled from the full job description

• Company car
• Eco vouchers, At MindCapture, you are not just taking on a new job. You are joining a community that values who you are and what you bring to the table.

You can count on:

• A competitive salary with a complete benefits package including 32 vacation days, meal and eco vouchers, DKV health insurance, group insurance, net expense allowance and a company car with fuel or charging card or mobility budget.
• Real ownership in your role where your voice matters and your input is heard.
• Personal growth support with coaching, tailored training and clear career paths that match your ambitions.
• The chance to work on projects with purpose for leading clients with a direct impact on a healthier and cleaner world.
• A warm and open company culture where teamwork, trust and connection are at the heart of everything we do.

• Final interview & welcome - In a final chat with our team, we close the process and warmly welcome you to MindCapture, guiding you towards a smooth start with us or at the client site.