Quality Engineer – Pre-Validation, CSV & AI Quality
Bangalore
5+ years

Role Overview
We are seeking a Pre-Validation and Computerized System Validation (CSV) Expert with 2 to 5 years of experience in GxP validation, quality assurance, and regulated software environments to contribute to the quality engineering and validation of enterprise-grade SaaS and AI-powered products.

The ideal candidate should have strong hands-on experience in risk-based validation, pre-validation activities, requirements assessment, validation strategy, test planning, traceability, IQ/OQ/PQ, data integrity, audit trail assessment, electronic records/signatures, and validation documentation for cloud-based and integrated systems.

The candidate will work closely with Engineering, Product, Testing, Implementation, Quality, Security, and Customer teams to assess requirements and risks early, identify validation gaps, define appropriate verification and testing approaches, review configuration and implementation evidence,



and ensure systems are fit for intended use in regulated manufacturing and life-sciences environments.

AI/GenAI – Must have: Hands-on use of AI for requirements analysis, risk assessment, test/OQ script generation, traceability analysis, validation document review, defect investigation, gap identification, and AI-assisted CSV workflows. Solid understanding of the need to independently verify AI-generated outputs and maintain GxP compliance, data integrity, confidentiality, and auditability.

Key Responsibilities
Pre-Validation & Validation Strategy
• Lead and execute risk-based pre-validation activities for product releases, customer implementations, configuration changes, integrations, and new functionalities in regulated environments.
• Review business, user, functional, and configuration requirements to identify validation impact, GxP relevance, critical functionality, data integrity risks, and test coverage needs.
• Define validation approaches, scope, deliverables, ac

📌 Pre-Validation, CSV (Bengaluru)
🏢 Mareana
📍 Bengaluru