QA-CSV Specialist & Site Key User

Our client, a leading life sciences organization, is seeking a specialist to provide quality oversight and functional governance for computerized systems. The role combines independent QA-CSV validation support for manufacturing automation with the site-wide implementation of a digital checklist management system.

• Provide independent QA-CSV oversight for projects, changes, and operations within a GxP environment.
• Review and approve validation deliverables, including risk assessments, specifications, and summary reports.
• Assess changes, deviations, and CAPAs for impact on product quality and data integrity.
• Coordinate the digitalization of paper-based processes into controlled digital workflows and checklists.
• Govern user access and system roles to ensure compliance with business needs and segregation of duties.
• Monitor system metrics and ensure records are closed within acceptable timelines.
• Provide functional guidance and support to stakeholders across the site.

• Bachelor or Master degree in Engineering, Automation, Computer Science, or Life Sciences.
• 3+ years of relevant experience in CSV, validation, and quality assurance within a GxP-regulated environment.
• Practical experience with lifecycle documentation, change control, deviation management, and CAPA.
• Knowledge of SDLC, EU GMP Annex 11, US FDA 21 CFR Part 11, GAMP 5, and data integrity principles.
• Strong collaboration and organization skills with a solution-oriented approach.
• You are fluent in English.

Nice to Haves

• Experience with PLC, SCADA, industrial automation networks, or infrastructure monitoring.
• Familiarity with digital workflow or electronic form management solutions.
• Knowledge of Dutch.

• 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.