Sandeep Vuduthuri

About Sandeep Vuduthuri

CQV/CSV Manager with 11+ years of experience in Project Management, Change Controls, development of all the validation / qualification documentation like User and Functional Requirement Specification, Configuration Requirements, DQ’s, Equipment and Computer System Classification Assessments, ERES Assessments, Data Integrity assessments, IQ’s, OQ’, PQ’s, SOP’s, Requirement Traceability Matrix (RTM) and Summary Reports. • Experience in qualification of Siemens MES, SAP, EMPOWER, MODA, LIMS, Siemens wincc, integrated Allen Bradley PLC systems, Siemens PLC, SCADA, PCS, HMI’s, Thinclients and FactoryTalk SCADA, Kepware, Emerson Delta V, OSI PI data historian, OSI PI DA instances, PI collective, PI ICU, PI-API, and PI-SDK, SQL express, Wonderware and Metasys. • Experience in developing and executing FAT, SAT, Commissioning, IQ, OQ & PQ for Aseptic Processing and Aseptic Fill and Monitoring systems, Tanks, Lyophilizer, Loader/Unloader, Filler, Tunnel, Depyrogenation Oven, Capper, Washers, Refrigerator, Freezers, Cold Box, Walk-in Stability Chambers, Isolator, Laminar Flow Hood, EISAI Visual Inspection, Optel Serialization, De-nester, Data Recorders, Plunger Rod Labeler, Heat Shrinkage Tunnel, Literature Inserter, Cartoner, Check Weigher and Case Packer. • Experience in overseeing Commissioning projects for Plant Steam, HQS, WFI, OFCA, AHU and HVAC units.• Experience in walkdown and verification of system drawings (P & IDs, as-builts, etc.)• Experience in authoring and reviewing Validation Summary Reports. • Performed Temperature Mapping studies (heat penetration and heat distribution qualification studies) using Kaye Validator Kaye Validator AVS, Lives, Ellabs, TempTales, Mastech and Omega Data Loggers.

Experience

1. Validation Lead

   Pfizer

   Jul 2025 — Present

   Lead CSV efforts for Veeva QRM, Change Management and oneCAPA implementation.• Gather requirements by collaborating with business and draft requirements in JIRA.• Track documentation in confluence.• Worked closely with Scrum Masters, Product Owner and testers on delivering committed stories/tasks in sprints.• Review and provide feedback for scripts developed by testers.• Conduct Daily Stand Ups.• Develop URS, Validation Plan, Risk Assessments, DI & Alarm Assessments and Final Reports.• Develop scripts in TOSCA and qTest.• Develop Design and Graphics Specifications for DeltaV and OSI PI.

Education

• Osmania University

  Bachelor's degree, Pharmaceutical Sciences

  2010 — 2014

• Lamar University

  Master's degree, Chemistry

  2014 — 2016