System Validation Engineer

4 days ago

Bengaluru, Karnataka, India Mercedes Benz Full time

Role Purpose:

The System Validation Engineer is responsible for planning, executing, and documenting validation activities for computerized systems, equipment, and processes to ensure compliance with regulatory standards such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5. The role ensures that all systems perform consistently and reliably according to defined requirements and that data integrity is maintained throughout the system lifecycle.

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.

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