Vishal Palla

About Vishal Palla

Validation Engineer (CQV) with experience in commissioning, qualification, and validation of Controlled Temperature Units (CTUs), laboratory and biopharmaceutical equipment, and cleanroom environments within GMP-regulated settings.Experienced in drafting and executing IOQ/PQ protocols, performing temperature mapping, HVAC qualification, and conducting airflow visualization (smoke studies) to support regulatory compliance (FDA, cGMP). Proficient in Kaye Validator, Ellab dataloggers, Kneat e-validation systems, and CMMS platforms.Skilled in Computer System Validation (CSV) for laboratory and GMP computerized systems, including authoring SCS, SRS, IQ, UAT, Traceability Matrix, SCM, and Validation Summary Reports. Experienced in GMP spreadsheet validation through requirements definition, risk assessment, test script development, and reporting.Strong technical writer with hands-on experience in deviation investigations, CAPA management, change controls, internal audit support, and regulatory inspection readiness. Adept at cross-functional collaboration with Quality, Engineering, and IT teams to deliver compliant, inspection-ready validation packages.

Experience

1. Validation Engineer Ii

   Charles River Laboratories

   Aug 2025 — Present · Memphis, TN, US

   Performed equipment qualification (IQ/OQ/PQ) for laboratory equipment and Controlled Temperature Units (CTUs) in compliance with GMP requirements.Authored and executed Installation, Operational, and Performance Qualification (IOQ/PQ) protocols to support equipment validation activities.Conducted Computer System Validation (CSV) for laboratory and GMP computerized systems using Kneat, ensuring data integrity and regulatory compliance.Developed and maintained CSV deliverables including System Classification Specification (SCS), System Requirements Specification (SRS), IQ, UAT, Traceability Matrix (TM), Software Configuration Management (SCM), and Validation Summary Reports.Led GMP spreadsheet validation by drafting user requirements, risk assessments, test cases/test scripts, and final validation reports.Executed and documented airflow visualization (smoke studies) for cleanroom environments to verify airflow patterns in accordance with GMP standards.Authored, collaborated on, and reviewed smoke study protocols and final reports, ensuring accuracy and regulatory readiness.Reviewed executed validation protocols and reports for completeness, accuracy, and compliance with internal SOPs and regulatory guidelines.Utilized qualification systems such as Ellab and Kaye for thermal mapping and environmental monitoring of equipment.Actively worked within Quality Management Systems (QMS) to initiate, manage, and close Change Controls, CAPAs, and Deviations.Recorded and tracked validation and maintenance activities using Kneat and CMMS systems, including work order documentation.Facilitated and participated in change control review meetings, internal audits, and inspection readiness activities for regulatory audits.Collaborated cross-functionally with Quality, Engineering, IT, and Operations teams to ensure timely and compliant validation deliverables.

Education

• Marist College

  Masters

• JNTUH College of Engineering Hyderabad

  Bachelor of Technology - BTech