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