Validation Engineer

Job Title:

Experience:

Location:

Job Summary:

Validation Testing Engineer

Key Responsibilities:

• Contribute to the overall

  Computer System Validation (CSV)

  deliverables of the project.
• Develop, execute, and maintain

  test scenarios

  ,

  test cases

  , and

  validation scripts

  in alignment with project requirements.
• Select appropriate

  testing methodologies

  ,

  techniques

  , and

  evaluation criteria

  to ensure thorough system validation.
• Draft, review, and approve validation documents such as:

• User Requirements Specifications (URS)

• Functional Specifications (FS)

• Design Specifications (DS)

• Installation Qualification (IQ)

• Operational Qualification (OQ)

• Performance Qualification (PQ)

• Traceability Matrices

• Configuration Documentation

• Error Logs

• Validation Summary Reports

• Ensure

  compliance

  with applicable regulatory standards such as

  21 CFR Part 11

  ,

  EU Annex 11

  , and

  GxP

  requirements.
• Collaborate closely with QA, development, and business teams to ensure test coverage and traceability.
• Participate in audits and inspections, providing necessary validation documentation and support.
• Maintain validation lifecycle documentation in line with corporate and regulatory standards.