Ramakrishna Ganjigunta

About Ramakrishna Ganjigunta

I’m a Manufacturing Execution Systems (MES) Engineer with 5+ years of hands-on experience supporting and implementing MES solutions in pharmaceutical and biotech manufacturing environments. I specialize in delivering compliant, production-ready MES systems that bridge manufacturing, automation, quality, and IT teams.My experience spans Werum PAS-X, Emerson Syncade, and Siemens Opcenter Execution Pharma, where I’ve designed and supported Electronic Batch Records (EBRs), ISA-88/ISA-95 recipe structures, reusable building blocks, equipment models, and material workflows across upstream, downstream, and packaging operations. I’ve worked extensively on converting paper batch records and legacy EBRS into standardized electronic workflows that improve data integrity, traceability, and operational efficiency.I have strong expertise in MES validation and CSV activities, including authoring and executing URS, FS, DS, IQ/OQ/PQ, traceability matrices, and functional test scripts, ensuring compliance with 21 CFR Part 11, GAMP 5, GMP, and GxP requirements. I regularly support change controls, deviations, CAPAs, and audit readiness for FDA and EMA inspections.On the integration side, I’ve connected MES platforms with SAP ERP, DeltaV DCS, Allen-Bradley PLCs, SCADA systems, historians (OSIsoft PI), weigh scales, barcode scanners, and printers to enable automated material movements, batch reconciliation, and genealogy tracking. I’m comfortable troubleshooting live production issues, performing root cause analysis, and supporting manufacturing during FAT, SAT, commissioning, and go-live.I also bring a strong technical foundation, with hands-on experience using SQL (T-SQL).NET, PowerShell, and reporting tools to build dashboards, reconciliation reports, and operational insights that improve batch visibility and decision-making.I enjoy working close to the shop floor, taking true system ownership, and partnering with manufacturing, QA, automation, and IT teams to deliver MES solutions that are right-first-time, compliant, and scalable.

Experience

1. Mes Engineer

   Merck

   Oct 2024 — Present · Durham, NC, US

   Designed functional recipe logic with user prompts, QA hold points, and conditional transitions to guide operators and enforce GMP rules.•Developed and validated equipment models for upstream bioreactors, buffer prep systems, and downstream purification/filling lines, improving electronic traceability.•Integrated Opcenter with SAP ECC, DeltaV DCS, and Allen-Bradley PLCs following ISA-95 standards, ensuring accurate data flow for orders, BOMs, and batch results.•Prepared validation test cases and traceability matrices to qualify MES–ERP–automation integrations under FDA 21 CFR Part 11 and GAMP 5.•Configured and maintained Electronic Batch Records (EBRs), workflows, and equipment models in Opcenter, covering dispensing, reactor operations, CIP/SIP, and packaging processes.•Developed and executed validation documents to test recipes, interfaces, and batch records, making sure all requirements were traceable and compliant with 21 CFR Part 11, GAMP 5, and GxP.•Developed SQL queries and.NET utilities for reconciliation reporting, integration monitoring, and batch status extracts.

Education

• Governors State University

  Master's degree, Information Technology

• Lovely Professional University

  Bachelor of Technology - BTech, Computer Science