Laxshmi T

Validation Engineer @Pfizer

NY, US

Oversaw IOPQ activities for complex process equipment, including Zonal Ultra Centrifuge, Tangential Flow Filtration (TFF) skids, 500L & Single-Use Bioreactors, Chromatography skids, Biosafety Cabinets, and Isolators.Directed the development and execution of Installation, Operational, and Performance Qualification (IOPQ) protocols for critical utilities, including HVAC, Milli-Q water, Deionized Water (DI), and Water for Injection (WFI) systems.Validated Electronic Batch Record (EBR) systems in alignment with 21 CFR Part 11, Annex 11, and GAMP 5, and led data migration validation including mapping, verification, and reconciliation of legacy data to GMP-compliant platforms.Developed and executed cleaning validation protocols and reports for manufacturing equipment, incorporating swab and rinse sampling methods to meet GMP and regulatory standards.Managed commissioning and qualification for controlled temperature units (coolers, freezers, incubators, environmental chambers) and conducted temperature mapping using Kaye Validator AVS, Kaye and Ellab data loggers.