Vineetha Prasad

Experience

1. Senior Mes Validation Engineer

   KBI Biopharma

   Feb 2025 — Present · US

   Led the validation of MODA-ES (versions 3.0 to 4.1) for electronic batch records (EBRs), including eEPR (Electronic Preparation Records), Dispensing Logs, and pH/Conductivity Logs in GxP manufacturing environments. • Authored and executed Installation and Operational Qualification (IOQ) protocols aligned with URS and Functional Specifications. • Developed and maintained Requirement Traceability Matrices (RTM), ensuring complete traceability from User Requirements to test steps. • Performed dry runs and peer reviews for validation protocols, addressing comments and ensuring accuracy in execution steps and expected results. • Collaborated cross-functionally with QA, CSV, IT, and Manufacturing teams to gather requirements, align test scripts, and resolve system discrepancies. • Ensured data integrity and 21 CFR Part 11 compliance for electronic records and audit trails across validated MODA-ES modules. • Supported ticket creation and defect tracking in Jira for deviations, enhancements, and validation-related findings. • Reviewed and validated system impact assessments (SIA), validation plans, and functional/design specifications for MODA-ES workflows. • Provided validation input for version upgrades and change control processes related to MODA-ES enhancements and integration. • Ensured compliance with GAMP 5 principles and internal SOPs throughout the validation lifecycle.