Sohail Sharif

Computer System Validation Engineer @Lonza

TX, US

Documented URS, IQ, OQ, and PQ for Version Control and Data Solutions systems, ensuring compliance with regulatory standards-Reviewed and authored URS, FRS, Validation Plans, Test Plans, Functional & Design Specifications, Qualification Protocols, and Test Cases for enterprise applications including Jira, DOORS, and SAP-based systems-Collaborated with IT Project Managers and Validation Analysts to track project status and ensure alignment with project schedules and compliance requirements-Created templates, SOPs, procedures, and manuals to support validation of infrastructure, lab equipment, analytical instruments, spreadsheets, and IT applications-Developed and executed Data Migration scripts, monitoring extraction and transfer processes for accuracy and integrity-Validated labeling applications and associated hardware in compliance with FDA’s General Principles of Software Validation and 21 CFR Part 11-Leveraged HP Quality Center for managing requirements, test plans, and test execution across validation projects-Authored and reviewed documentation supporting infrastructure qualification, IT tool validation, and regulatory compliance initiatives.

Indiana Wesleyan University

Master's degree