Job Description :

Validation Engineer

Job Summary

The Validation Engineer is responsible for planning, executing, and documenting validation activities to ensure systems, software, and equipment comply with regulatory and quality standards.

Responsibilities

  • Develop and execute validation plans, protocols, and reports

  • Perform IQ, OQ, and PQ validation activities

  • Ensure compliance with FDA, ISO, and GxP regulations

  • Review system requirements, risk assessments, and test cases

  • Support audits, inspections, and regulatory submissions

  • Collaborate with engineering, quality, and manufacturing teams

  • Manage change control and validation documentation

Skills

  • Computer System Validation (CSV) and equipment validation

  • IQ, OQ, PQ methodologies

  • FDA, ISO, GxP compliance

  • Risk management and documentation

  • Test execution and defect tracking

  • Quality systems and SOPs

  • Strong analytical and communication skills

             

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