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 our 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 (e.g., 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 (e.g., MES, SCADA, 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, including:

• A competitive salary, depending on your knowledge and experience.
• A 3% year‑end allowance and an annual bonus based on individual and company performance.
• A minimum of 35.5 days of paid leave.
• Travel expense reimbursement and a solid pension plan.
• A high‑quality company restaurant offering fresh and healthy options daily.
• Excellent accessibility: the train station is located directly at the main entrance, and ample parking is available.
• A beautiful private park on site, ideal for walking, taking a break, or relaxing.
• Mental wellbeing support via Lyra Health for you and your family members.
• Access to a dedicated prayer/meditation room.
• Extensive career development opportunities thanks to the size of the site and the presence of many disciplines and global departments represented in Boxmeer.
• A workplace within an organization that continues to grow and evolve.

Animal Health Division
Our Animal Health division is a trusted global leader in veterinary medicine, dedicated to the health and well-being of animals. We are a global team of professionals working together to make a positive difference in animal care and the world’s food supply and have a deep sense of responsibility towards our customers, consumers, animals, society and our planet. We offer one of our industry’s most innovative portfolio of products, services and technologies that serve to prevent, treat, and control diseases across all major farm and companion animal species.

                      

For questions about this vacancy
Please send an email including the vacancy number and job title to the following email address: [email protected]

 

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

Preferred Skills:

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Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

08/2/2026

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