CSV Engineer

We are looking for an experienced CSV Engineer to support validation activities across multiple pharmaceutical manufacturing projects in Europe. This role will involve working on GMP-regulated computerized systems within manufacturing, packaging, and laboratory environments. You will play a key role in ensuring systems are compliant with regulatory standards and support ongoing digital and automation initiatives across sites.

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• Execute the CSV lifecycle including validation planning, risk assessments, and documentation (URS, FS, DS, IQ, OQ, PQ).
  
• Support validation of GxP computerized systems including manufacturing, laboratory, and quality systems.
  
• Work closely with automation, IT, quality, and engineering teams across multiple European project sites.
  
• Ensure compliance with GMP, GAMP5, and 21 CFR Part 11 requirements.
  
• Participate in system implementations, upgrades, and remediation projects.
  
• Review and approve validation documentation and ensure audit readiness.
  

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• Minimum 5+ years’ experience in Computer System Validation within the pharmaceutical or life sciences industry.
  
• Strong knowledge of GMP environments and regulatory requirements.
  
• Experience validating systems such as MES, LIMS, SCADA, ERP, or laboratory systems.
  
• Ability to work on multi-site projects across Europe.
  
• Strong documentation, stakeholder management, and communication skills.
  
• Degree in Engineering, Computer Science, Life Sciences, or related field.
  

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• Experience working on large-scale pharmaceutical manufacturing projects or site expansions.
  
• Knowledge of data integrity and computerized system compliance. xcfaprz
  
• Exposure to automation systems (DeltaV, Siemens, Rockwell) is beneficial.