System Validation Engineer

Role Purpose:

System Validation Engineer

Key Responsibilities:

1. Validation Planning & Execution

• Prepare and execute validation deliverables including Validation Master Plan (VMP), URS, DQ, IQ, OQ, and PQ protocols and reports.
• Coordinate and perform validation testing of computerized systems, manufacturing equipment, and laboratory instruments.
• Ensure that validation documentation meets internal and regulatory compliance standards.

2. Computer System Validation (CSV)

• Conduct risk assessments for GxP-relevant systems and define appropriate validation strategies.
• Validate systems in accordance with GAMP 5 and data integrity principles.
• Collaborate with IT, QA, and system owners for system implementation and change management.
• Verify system functionality, security, audit trail, and backup/restore functionalities.

3. Documentation & Compliance

• Maintain traceability matrices linking requirements, test cases, and results.
• Support audit readiness by ensuring all validation documents are current and accessible.
• Review vendor qualification documents and software development lifecycle (SDLC) deliverables.
• Manage deviation handling, CAPA, and revalidation activities as needed.

4. Continuous Improvement

• Identify process improvements to optimize validation workflows.
• Stay updated on evolving validation regulations and industry best practices.
• Provide training and guidance on validation standards to relevant stakeholders.