Computerised System Validation (csv) Projects Lead

Merck Merck · Pharma · North Brabant, Netherlands

This role is for a Computerised System Validation (CSV) Projects Lead at Merck's Animal Health division. The primary focus is on ensuring consistency, quality, and adherence to global standards and regulatory requirements (GxP, 21 CFR Part 11) in validation activities for IT and automation systems within a highly regulated manufacturing environment. The role involves leading validation planning, providing oversight and coaching to CSV analysts, and collaborating with IT, Quality, and Manufacturing teams.

What you'd actually do

  1. Drive standardization and adherence to CSV methodologies and procedures based on global standards
  2. Lead validation planning and design activities across project teams
  3. Provide oversight, coaching, and guidance to CSV analysts within the organization
  4. Ensure quality oversight of change control and validation activities for regulated systems (including 21 CFR Part 11 compliance)
  5. Collaborate with IT, Quality, and Manufacturing teams to ensure compliant and efficient system delivery

Skills

Required

  • 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)
  • Fluent in English

Nice to have

  • Experience with digital tools supporting validation processes
  • Preferably Dutch

What the JD emphasized

  • Computerised System Validation (CSV)
  • GxP
  • regulated systems
  • 21 CFR Part 11 compliance