Rishika Reddy Vanteru
Validation Engineer
- Role
- Engineer at Pfizer
- Location
- Charlotte, NC, US
- LinkedIn followers
- 500 followers
About Rishika Reddy Vanteru
As a Validation Engineer with over 9 years of experience in the pharmaceutical, medical…
Experience
Engineer
Mar 2023 — Present
Led CQV activities for sterile aseptic filler systems including vial fillers, stoppering systems, and VHP-integrated isolators.· Developed CQV lifecycle documentation: CQV Master Plan, URS, DQ, Risk Assessments (FMEA), IQ, OQ, PQ, RTM, and summary reports.· Executed loop checks, dry runs, and media fills to validate end-to-end system functionality.· Conducted smoke studies and classified area airflow visualization in ISO 5/7 environments.· Performed filler component testing: nozzle alignment, servo motor tuning, filling accuracy, and HEPA filter integration.· Collaborated with vendors and automation engineers for SAT, I/O verifications, and DeltaV/PLC controls.· Managed deviations, CAPAs, and change controls in TrackWise to support compliant system release.· Managed deviations, CAPAs, and change controls using TrackWise; conducted FMEA-based risk assessments.· Reviewed and authored validation deliverables including URS, DQ, RTM, and Validation Summary Reports.· Collaborated with QA, operations, and engineering to ensure audit readiness and timely system release.· Performed temperature mapping using Kaye Validator for autoclaves, ovens, and lyophilizers; analyzed deviations and implemented corrective actions.· Authored validation deliverables including URS, DQ, risk assessments (FMEA), and traceability matrices for sterile manufacturing systems.· Executed fill volume verification studies, fill line integration tests, and solution hold time validations for biologics.· Participated in media fill simulations with CCI testing to ensure aseptic integrity.· Drafted and reviewed protocols and reports for smoke studies and HVAC qualification in classified cleanrooms (ISO Class 5–8).· Managed deviations, CAPAs, and change controls in TrackWise during filler equipment commissioning.
Education
Osmania University
Biotechnology
Osmania University
Bachelor's degree, Biotechnology
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