Computer System Validation (CSV) Specialist

Our client, a leading organization in the life sciences sector, is seeking a professional to support computer system validation activities. The role focuses on ensuring that computerized and automated systems in GxP-regulated environments are fit for purpose and comply with both regulatory requirements and internal standards.

• Draft comprehensive validation documentation for computerized systems.
• Perform Computer System Validation (CSV) activities for DCS and PLC systems and interfaces.
• Implement Design Qualification (DQ) protocols for automated systems.
• Execute validation testing including IQ, OQ, and PQ phases.
• Identify and mitigate compliance risks throughout the project.
• Coordinate with multidisciplinary teams including engineering and quality departments.

• You have 3+ years of experience in validation activities with a focus on Computer System Validation (CSV).
• You bring experience in validating automated systems and knowledge of Data Integrity principles.
• You possess expertise in compliance requirements such as 21 CFR Part 11, EU Annex 11, and GAMP 5.
• You have experience with quality assurance processes including change control and deviation management within a GMP environment.
• You're analytical and structured with strong technical documentation and communication skills.
• You are fluent in English.

Nice to Haves

• Knowledge of process automation systems such as Emerson DeltaV or Siemens PLC/HMI.
• Experience with Equipment Validation, Kneat, and risk-based validation approaches.
• Basic knowledge of USP and DSP processes.

• 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.