System Validation Engineer QA

Hi,Role : System ValidationLocation : Costa Rica (Hybrid- near your Infosys office)Total Experience - 10+ Years
Role Overview
We are looking for a experienced Validation resource in Computerized System Validation (CSV) within the Life Sciences / Pharma/ Biotech domain. The candidate will lead end-to-end validation activities for enterprise-level software systems.
Key Responsibilities
Support end-to-end CSV/CSA activities for system implementations, upgrades, and enhancements.Prepare and review Validation Plans, URS, FRS, Risk Assessments, Traceability Matrix, Validation Summary Reports, and related deliverables.Develop, review, and execute IQ, OQ, PQ, UAT, regression, and functional test scripts.Document, track, and support closure of defects, deviations, and discrepancies.Ensure traceability between requirements, risks, and testing evidence.Support audit readiness, inspections, CAPA, and periodic review activities.Participate in validation process improvements and automation initiatives.Ensure compliance with 21 CFR Part 11, EU Annex 11, Data Integrity (ALCOA+)Hands-on experience in GxP-regulated systems validation and testing.
Required Skills & Competenciesknowledge of Computerized System Validation (CSV) lifecycle, CSA and SDLC.Hands-on experience with validation documentation (URS, FRS, DS, IQ/OQ/PQ, RTM).Good understanding of GxP processes and regulatory compliance frameworks.Experience with tools such as HP ALM, JIRA, Veeva Vault, kneat validation tool etc.Knowledge of risk-based validation and Computer Software Assurance (CSA).Exposure to cloud/SaaS validationStrong analytical, documentation and communication skills.Ability to work in global, cross-functional teams.Experience working with US & European clients.

Thank [email protected]