Tool Validation Engineer

Experience : 4+ years

Location : Bangalore

Key Responsibilities
Author, review, and maintain validation deliverables including URS, FS, DS, Risk Assessments, Validation Plans, Protocols, Traceability Matrices, and Reports.
Develop, execute, and document IQ, OQ, and PQ protocols for equipment, systems, utilities, software applications, and computerized systems.
Perform validation activities according to approved procedures, regulatory requirements, industry standards, and Quality Management System (QMS) frameworks.
Conduct risk assessments using risk-based validation and Computer Software Assurance (CSA) methodologies to determine validation scope, testing strategies, and acceptance criteria.
Develop test protocols, document objective evidence, investigate deviations, and maintain complete traceability throughout the validation lifecycle.
Prepare validation summary reports to support formal release, approval, and change management activities.
Assess computerized systems for compliance regarding electronic records and electronic signature requirements.
Ensure compliance with FDA 21 CFR Part 11, FDA 21 CFR Part 820, GxP requirements, ISO 13485, ISO 14971, and GAMP 5.




Apply ALCOA+ data integrity principles to validation documentation, test evidence, electronic records, and system controls.
Support vendor assessments and leverage supplier validation packages where appropriate to optimize testing efforts.
Participate in change control activities, impact assessments, and revalidation efforts for system modifications, upgrades, and patches.
Conduct periodic reviews to verify that production systems and equipment continuously maintain a validated, compliant operational state.
Support system decommissioning activities including data archival, record retention, migration strategy, and final lifecycle documentation updates.
Collaborate cross-functionally with QA, Engineering, Manufacturing, Operations, Regulatory Affairs, and IT to support project delivery.
Support internal audits, external audits, and regulatory inspections by providing validation documentation and compliance evidence.
Drive continuous improvement initiatives for validation processes, procedures, templates, and documentation standards.Role & responsibilities

Preferred candidate profile

📌 Tool Validation Engineer Bengaluru
🏢 Larsen u0026 Toubro (Lu0026T)
📍 Bengaluru