CSV & Computer System Validation Specialist

Our client, a leading organization in the life sciences sector, is seeking a professional to oversee the quality and validation of computerized laboratory systems. The role focuses on system administration and validation activities to ensure compliance with international regulatory standards in a laboratory environment.

• Manage GxP laboratory system software including installation, data backups, and archival of critical data.
• Execute validation activities for new computerized systems by writing and reviewing protocols and reports.
• Identify and troubleshoot computer-related issues while coordinating deviations and change control processes.
• Audit site computerized systems and monitor the implementation of corrective and preventive action plans.
• Collaborate with laboratory end users to facilitate the efficient use of software and technical infrastructure.
• Ensure that internal regulations remain aligned with the latest regulatory requirements and industry standards.

• Bachelor or Master degree in a scientific or technical field.
• You have 1+ years of experience in computer system validation (CSV) within a GMP or GxP environment.
• You bring knowledge of GAMP, Data Integrity, and IQ/OQ/PQ methodologies.
• You possess experience with 21 CFR Part 11 and technical software administration.
• You have excellent technical writing skills and a proactive, solution-oriented mindset.
• You are fluent in English.

Nice to Haves

• Familiarity with Cell and Gene Therapy regulations.
• Experience with software setup in OT environments.

• 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.