Validation Engineer ( Medical Device Domain)

Key Responsibilities

• Plan, coordinate and execute full lifecycle validation of computerized systems, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification)
• Develop and maintain validation deliverables: plans, protocols, test scripts, traceability matrices, summary reports
• Conduct system risk assessments, create and review URS (User Requirements Specification), functional specifications, and design documentation
• Ensure regulatory compliance with frameworks such as FDA 21 CFR Part 11, GAMP 5, EU Annex 11, ISO 13485, IEC 62304, GLP/GMP/GCP as applicable
• Collaborate with IT, QA, R&D, and business units to manage change controls, deviations, and re-validation efforts
• Prepare documentation for and support internal/external audits and inspections; address regulatory inquiries
• Conduct periodic system reviews and decommissioning/retirement activities as n...