CSV Engineer

Our client, a leading pharmaceutical organization, is seeking a professional to manage and execute validation activities for computerized systems. The project involves ensuring that all cGMP-critical software packages remain compliant with regulatory and user requirements.

• Develop, implement, and execute validation activities including URS, SIA, DQ, IQ, OQ, PQ, RV, and TM.
• Generate and manage validation documentation such as protocols and reports from approval through to implementation.
• Maintain the validated status of computerized systems to ensure continuous compliance with cGMP and cGLP standards.
• Provide technical assistance on current validation requirements and emerging industry testing practices.
• Assess the impact of system changes on validated status and update documentation accordingly.
• Investigate and troubleshoot validation issues to support project timelines and quality standards.

• You have 3+ years of experience in a pharmaceutical GMP environment.
• You possess comprehensive knowledge of Computer Systems Validation (CSV) and relevant quality and compliance regulations.
• You bring experience in the validation of software packages and computerized systems.
• You're able to work independently, learn quickly, and execute projects according to plan.
• You possess strong troubleshooting skills and the ability to manage complex validation issues.
• You are fluent in English and Dutch.

Nice to Haves

• Familiarity with international validation requirements such as FDA or EU standards.
• Experience with RV and TM documentation.

• Enjoy a competitive salary package with extra perks that recognize your talent.
• Advance your career with a clear growth path, coaching, and mentoring to support you.
• Thrive in a dynamic and supportive environment where you can truly make an impact.
• Work when and where you perform best, ensuring an optimal work-life balance.
• Choose a flexible transport solution, from a company car to a public transport subscription.
• Expand your network and enjoy unforgettable moments at exclusive events and afterworks.
• Grow your skills with external courses and our in-house Pauwels Academy.
• Work on exciting projects with industry leaders in Life Sciences, Engineering & Digital.
• Seize opportunities at every level, from a strong start to career acceleration and expert collaboration.