Verification & Validation (CSV) Engineer

Vinay Gunamoni

Eden Prairie, Minnesota, United States • *****.*********@*****.*** • +1-475-***-****

SUMMARY

Verification and Validation (V&V) Engineer with experience in validation engineering, Computer System Validation (CSV), IQ/OQ/PQ, system-level verification, functional and regression testing, requirements traceability, and test documentation. Executed 35+ validation and verification cycles and developed 75+ validation deliverables, contributing to a 12% reduction in validation cycle time, an 18% improvement in system reliability, and zero major non-conformities across supported audits. Proficient in verification protocols, test cases and scripts, Requirements Traceability Matrices (RTMs), risk assessments, defect investigation, root-cause analysis, Microsoft Excel, SQL, change control, and data validation, with a focus on objective test evidence, requirements-based testing, and continuous improvement. SKILLS

• Systems Verification & Validation (V&V)

• System-Level Verification & Performance Testing

• Test Strategy & Test Plan Development

• Test Protocol Development & Execution

• Requirements Analysis & Traceability Matrix (RTM)

• Functional & Regression Testing

• Characterization Testing

• Risk Assessment & Impact Analysis

• Test Results Analysis & Technical Reporting

• Defect Tracking & Root-Cause Analysis

• Test Evidence & Data Integrity

• Test Case & Test Script Development

• IQ/OQ/PQ Qualification

• Change Control & Verification of Changes

• Corrective Actions & Continuous Improvement

EXPERIENCE

Validation Engineer Mikros Engineering, Inc Minnesota,USA November 2025 - Present

• Executed 15+ validation protocols, including IQ/OQ/PQ testing, for computerized systems, achieving 100% adherence to applicable validation requirements and reducing validation cycle time by 12%.

• Authored 40+ validation deliverables, including validation plans, test protocols, test scripts, Requirements Traceability Matrices (RTMs), and final reports, strengthening objective test evidence and audit readiness.

• Performed functional, regression, and validation testing across systems and applications, identifying and resolving 25+ defects and improving system reliability by 18%.

• Translated user and system requirements into testable criteria and acceptance conditions in collaboration with Engineering, Quality, and IT teams, reducing requirement-related rework by 15%.

• Maintained change-control records, impact assessments, and periodic reviews for 10+ validated systems, preserving 100% requirements-to-test traceability during documented system changes.

• Analyzed test results, validation data, and system performance using Microsoft Excel, MS Office, and database tools, improving validation reporting efficiency by 20% and supporting evidence-based engineering decisions.

• Investigated validation failures, deviations, and unexpected test results through structured root-cause analysis, coordinating corrective actions and improving first-pass validation success by 16%.

• Verified system requirements and acceptance criteria against documented test evidence, maintaining complete validation records and supporting technical and quality reviews.

Validation Engineer S.K. Steel Industries India December 2022 - November 2024

• Executed 20+ validation and verification cycles for systems, equipment, and software applications using approved test plans and risk assessments, improving validation efficiency by 15% and achieving 100% acceptance-criteria compliance.

• Developed 35+ validation protocols, test cases, test scripts, and summary reports, improving documentation accuracy by 20% and maintaining complete, review-ready test records.

• Identified and tracked 30+ system, equipment, and validation defects, coordinating investigations and corrective actions with Engineering and Quality teams to achieve a 90% on-time resolution rate and reduce recurring issues by 18%.

• Analyzed validation results and system-performance data using Microsoft Excel, spreadsheets, and database query tools, improving reporting accuracy by 22% and reducing data discrepancies by 15%.

• Reviewed requirements, designs, and test-related risks in 10+ cross-functional reviews, identifying concerns early and contributing to a 12% reduction in downstream rework.

• Verified system and equipment performance against defined specifications and acceptance criteria, documenting deviations, test results, and corrective actions to strengthen verification evidence and system reliability.

• Diagnosed validation failures, deviations, and recurring technical issues through root-cause analysis and structured troubleshooting, supporting corrective actions that improved first-pass validation results by 14%.

• Supported 5+ internal and external quality audits by organizing validation records, test evidence, protocols, and traceability documentation, contributing to zero major non-conformities and improving audit readiness by 25%. EDUCATION

Master of Science - Information Technology and Management Concordia University-St.Paul St. Paul, MN 2026

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