Role Description

Hiring: Validation Engineer We are looking for a Validation Engineer with 5-8 years of experience to join our team and support validation activities for regulated systems and applications within the Life Sciences and Clinical Research domain.

Key Requirements: Experience in Computer System Validation (CSV), Software Validation, or Quality Assurance. Solid understanding of Validation Lifecycle, SDLC, STLC, IQ, OQ, PQ, URS, and RTM. Knowledge of GxP, 21 CFR Part 11, Annex 11, and regulatory compliance requirements.

Experience in preparing and executing validation protocols, test scripts, and validation documentation. Familiarity with tools such as Jira, ALM, or Azure DevOps. Strong analytical, troubleshooting, and documentation skills.

Responsibilities: Execute validation activities for applications, systems, and business processes. Create and maintain validation plans, protocols, reports,



and traceability matrices. Perform risk assessments and impact analyses for system changes. Support system implementations, enhancements, and upgrades. Collaborate with cross-functional teams to ensure compliance and quality standards. Support audit and inspection readiness activities.

Preferred: Experience in Life Sciences, Clinical Research, Pharmaceutical, or Healthcare domains. Exposure to SaaS platforms and cloud-based systems. Understanding of Agile methodologies and regulatory compliance frameworks.

Skills

GxP, CSV, EU Annex 11, FDA 21 CFR Part 11, Validation Engineering, Compliance Management, Risk Management, Requirements Gathering, SDLC, Jira, Process Documentation

📌 Lead I - Software Testing (Chennai)
🏢 UST
📍 Chennai