Sivani Chowdary

Automation Engineer | DeltaV DCS, PLC/SCADA & MES Expert | GMP, GAMP5 & 21 CFR Part 11 Compliance

Role
Automation Engineer at Sarepta Therapeutics
Location
Cambridge, MA, US
LinkedIn followers
500 followers

About Sivani Chowdary

Hands-on Automation Engineer with 6+ years of experience in GMP manufacturing environments, specializing in DeltaV DCS, PharmaSuite MES, Allen-Bradley & Siemens PLCs, and SCADA/BAS systems.Experienced in designing, programming, and commissioning batch automation systems, translating complex production recipes into ISA-88 compliant control logic.Developed intuitive HMI dashboards for operators to monitor temperature, flow, pressure, and critical process parameters in real-time.Integrated DeltaV Batch Executive, Historian, and alarm strategies with MES and SCADA systems, ensuring reliable, compliant data flow for electronic batch records (EBR).Skilled in CSV lifecycle management including URS, FS, IQ, OQ, PQ, change controls, and deviation handling to maintain audit-ready systems aligned with GAMP 5 and 21 CFR Part 11.Led commissioning, troubleshooting, and real-time support for GMP-critical equipment including bioreactors, autoclaves, washers, and BAS systems.Collaborated closely with cross-functional teams: instrumentation, QA/validation, electrical, and utilities, ensuring smooth integration, calibration, and operation of automation systems.Experienced in SCADA/PLC system upgrades, migrations, and maintenance, including Allen-Bradley ControlLogix, Siemens S7/TIA Portal, Rockwell FactoryTalk, and Wonderware.Provided operator and support team training on DeltaV interfaces, alarm management, and batch execution, enabling reliable day-to-day operations.Passionate about leveraging automation and process control to improve efficiency, reduce manual intervention, and support scalable, compliant manufacturing operations.

Experience

  1. Automation Engineer

    Sarepta Therapeutics

    May 2023 — Present · MA, US

    Designed and programmed DeltaV Phase Logic Modules (PLMs) and Equipment Modules to manage startup, process monitoring, and shutdown phases, ensuring precise control of critical parameters such as temperature, flow, and pressure.Developed custom DeltaV Operate HMI displays, providing operators with intuitive dashboards for batch control, real-time trending, alarm management, and system diagnostics.Integrated DeltaV Batch Executive to enable recipe-driven operations, enforcing batch sequencing, unit coordination, and parameter setpoint management with secure operator access.Configured DeltaV Historian to capture detailed batch data for traceability, performance analysis, and generation of 21 CFR Part 11-compliant audit trails and electronic records.Collaborated with instrumentation, electrical, and utilities teams to select, install, and calibrate sensors, actuators, and utility systems, ensuring reliable DeltaV integration and safety interlocks.Implemented advanced recipe management and parameter versioning within the DeltaV system, enabling controlled and auditable modifications to batch processes under validated conditions.Worked closely with QA and validation teams to prepare and execute DeltaV-specific validation protocols (IQ/OQ/PQ), ensuring full compliance with GAMP 5 and regulatory requirements.Performed root cause analysis and real-time troubleshooting within the DeltaV system during commissioning to resolve issues related to signal mapping, module execution order, utility stability, and device communications.Delivered hands-on training for operations staff on DeltaV batch control interfaces, alarm handling, and procedural workflows, supporting successful handover and sustained operational excellence.

Education

  • Acharya Nagarjuna University

    Bachelor's degree, Mechanical Engineering

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Sivani Chowdary — Automation Engineer at Sarepta Therapeutics in Cambridge, MA, US | Unifers