Validation Engineer

Job Description & Skill Requirement:Develop and execute Computer Software Validation (CSV) deliverables including:* Validation Plans (VP)* User Requirements Specifications (URS)* Functional Specifications (FS)* Risk Assessments* Installation Qualification (IQ)* Operational Qualification (OQ)* Performance Qualification (PQ)* Validation Summary Reports (VSR)Conduct risk-based validation assessments and determine validation strategies.* Review software requirements and design documentation to ensure testability and compliance.* Develop validation protocols and test scripts for commercial off-the-shelf (COTS), cloud-based, and custom-developed applications.* Execute validation testing and document results, deviations, and corrective actions.* Support software implementation, upgrades, patches, migrations, and retirement activities.* Manage software change controls and assess validation impact.* Collaborate with IT, Quality, Engineering, Manufacturing, Clinical, and Regulatory teams.* Participate in internal and external audits and regulatory inspections.* Maintain validation traceability matrices and validation lifecycle documentation.