Tool validation Engineer

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