Computerised System Validation (CSV) Projects Lead

Job Description

We are looking for a structured and influential validation expert who can drive consistency, quality, and excellence in Computerised System Validation across complex project environments.

For our Animal Health location in Boxmeer, we are looking for a Computerised System Validation (CSV) Projects Lead.

Welcome to our team

Our Animal Health site in Boxmeer is part of a global network dedicated to the development and production of high-quality animal health products, operating under strict GxP regulations.

Within Global Animal Health Manufacturing IT (AHIT), we deliver IT and automation solutions to our manufacturing sites in Boxmeer and De Bilt. This includes a wide range of technologies such as PLCs, SCADA systems, historians, MES platforms, and supporting IT applications—all aimed at enabling seamless data flow and efficient business operations.

You will be part of a dynamic and collaborative environment where IT, Quality, and Manufacturing come together to deliver reliable and compliant digital solutions.

About the role

As a CSV Projects Lead, you are responsible for driving consistency and excellence in Computerised System Validation (CSV) across multiple project teams. You play a key role in ensuring that validation activities meet global standards and regulatory requirements while enabling efficient project delivery.

In this role, you combine hands-on contribution to validation activities with leadership and oversight. You guide CSV analysts, strengthen CSV capabilities within the organization, and ensure alignment with the Animal Health Quality Management System.

You work closely with Business Technology Partners, project teams, and global stakeholders, and report to the Site Digital Technology Lead, with a dotted line to the global CSV and Quality lead.

Key responsibilities

• Drive standardization and adherence to CSV methodologies and procedures based on global standards
• Lead validation planning and design activities across project teams
• Provide oversight, coaching, and guidance to CSV analysts within the organization
• Ensure quality oversight of change control and validation activities for regulated systems, including 21 CFR Part 11 compliance
• Collaborate with IT, Quality, and Manufacturing teams to ensure compliant and efficient system delivery
• Promote a highly collaborative and customer-focused culture across local and global teams
• Support the continuous improvement of CSV processes, tools, and capabilities
• Ensure alignment with the Animal Health Quality Management System
• Act as a key point of contact for CSV-related topics within projects and across stakeholders

Your profile

• Bachelor’s degree in Computer Science, IT Engineering, or a related field, or equivalent experience
• Minimum of 5 years’ experience in a highly regulated manufacturing environment, such as pharma, biotech, food, or chemical industry
• At least 8 years of proven experience in Computerised System Validation (CSV)
• Strong knowledge of GxP environments and validation requirements
• Experience with validation of manufacturing and IT systems, such as MES, SCADA, and PLCs
• Preferably experience with digital tools supporting validation processes
• Strong analytical and organizational skills
• Excellent communication and stakeholder management skills
• Fluent in English and preferably Dutch

What we offer

We offer a truly global, dynamic, and challenging environment where digital excellence directly supports patient and animal health. You can expect strong opportunities for professional growth and a competitive total rewards package.

Required Skills

Animal Handling, Audit Management, Biopharmaceutical Industry, Business Process Improvements, Business Technology, Client-Centric, Computer Science, Data Management, Digital Technology, Global Supply Chain, Interpersonal Communication, Manufacturing Environments, Problem Management, Quality Control Management, Quality Management, Real-Time Programming, Software Development Life Cycle (SDLC), Veterinary Medicine, Veterinary Pathology