Job Description

We are looking for an experienced CSV / CSA Validation Engineer to ensure that IT systems are validated, compliant, and reliable within a regulated environment. This role focuses on assessing, validating, and documenting computer systems in accordance with GxP requirements, while supporting system implementations, upgrades, and changes. 

You will work closely with business stakeholders, QA, and cross-functional Agile teams to ensure systems meet regulatory standards and business needs. The ideal candidate has a strong understanding of risk-based validation (CSA), regulatory frameworks, and the full system validation lifecycle. 

Experience / Skills required: 

Must have: 

  • 4+ years of hands-on experience in Computer System Validation (CSV) and/or Computer Software Assurance (CSA) within regulated industries (pharma, biotech, medical devices, life sciences) 
  •  Strong practical knowledge of GAMP 5, 21 CFR Part...

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