MES Consultant & Validation Engineer

VIJAY KUMAR NAKKALA

EMAIL: *************@*****.*** PHONE: +1-469-***-****

PROFESSIONAL SUMMARY:

•MES Consultant / Engineer with 10+ years of experience designing, configuring, implementing, integrating, validating, deploying, and supporting MES solutions across pharmaceutical, biotechnology, medical device, and regulated manufacturing environments.

•Strong experience with Emerson Syncade, Siemens Opcenter/Camstar, Werum PAS-X, and Rockwell PharmaSuite, supporting Electronic Batch Records (eBR), recipe configuration, production workflows, material tracking, genealogy, traceability, and equipment integration.

•Experienced in GxP, GMP, GAMP 5, Computer System Validation (CSV), FDA 21 CFR Part 11, GDP, data integrity, IQ/OQ/PQ, CAPA, and validation documentation.

•Experienced in integrating MES platforms with ERP, LIMS, PLC, SCADA, OPC/OPC UA, historians, and shop-floor automation systems using REST APIs and other integration technologies.

•Strong programming and database experience with SQL, Python, C#, .NET, SQL Server, Oracle, and REST APIs for MES troubleshooting, reporting, automation, integration, and manufacturing data analysis.

•Experienced in Electronic Batch Records (EBR), electronic work instructions, production execution, routing, genealogy, serialization, traceability, recipe management, material tracking, equipment integration, SPC, and OEE.

•Strong experience supporting MES technical environments involving Microsoft SQL Server, Oracle Database, Azure SQL Database, Windows Server, application interfaces, database connectivity, and manufacturing data systems.

•Experienced in preparing Functional Specification Documents (FSD), Design Specifications (DS), Configuration Specifications (CS), validation documentation, deployment documentation, and change/release documentation.

•Proven ability to coordinate with manufacturing engineering, automation engineering, quality, validation, IT, business stakeholders, and cross-functional technical teams to deliver MES implementations.

•Strong troubleshooting and root-cause-analysis experience across MES applications, databases, integrations, shop-floor systems, and manufacturing data flows.

•Experienced in MES deployment across multiple production lines, production cutover, release management, system upgrades, patch deployments, and post-production stabilization.

EDUCATION:

Master’s in information science and technology August-2012--Dec-2013

University of New Haven

Bachelor of Technology (B. Tech) in Electrical and Electronics Engineering (June 2008 – May 2012)

Mallareddy University College of Engineering- Hyderabad, India

TECHNICAL SKILLS

Category

Technologies / Skills

MES Platforms (Core)

Emerson Syncade, Siemens Opcenter/Camstar, Werum PAS-X, Rockwell PharmaSuite

MES Platforms (Exposure)

SAP ME, Apriso, Emerson Syncade

ERP Systems

SAP ECC, SAP S/4HANA, Oracle ERP

Manufacturing Execution

Electronic Batch Records (eBR), Recipe Management, Manufacturing Workflows, Production Execution, Electronic Work Instructions, Material Tracking, Genealogy, Traceability, Serialization

Automation & IIoT

PLC, SCADA, OPC UA, MQTT, ISA-95, Industrial IoT (IIoT), RFID, Barcode Systems

Programming Languages

SQL, Python, C#, .NET, SQL Server, Oracle, REST APIs

Databases

Microsoft SQL Server, Oracle Database, Azure SQL Database

Integration Technologies

ERP, LIMS, PLC, SCADA, OPC/OPC UA, REST APIs, Historians, WMS

Reporting & Analytics

Power BI, SSRS, SQL Reporting, Manufacturing Dashboards, KPI/OEE Reporting

Validation & Compliance

FDA 21 CFR Part 11, GMP, GxP, GAMP 5, Computer System Validation (CSV), IQ/OQ/PQ, CAPA

Cloud & DevOps

Microsoft Azure, Azure DevOps, Git, Jenkins

Methodologies & Tools

Agile (Scrum), Waterfall, Jira, Confluence, Microsoft Visio

WORK EXPERIENCE:

Role: Lead MES Consultant Jan 2023 – Present

Client: Perrigo Company plc, Boston, MA (Remote)

Responsibilities:

•Lead the design, implementation, configuration, integration, deployment, and production support of enterprise MES solutions across manufacturing plants.

•Coordinate technical MES delivery with manufacturing engineering, automation engineering, quality, validation, IT, and business stakeholders.

•Design MES architecture integrating PLC, SCADA, shop-floor equipment, ERP, IoT devices, and manufacturing systems to provide real-time production visibility.

•Configured and supported MES manufacturing workflows including Electronic Batch Records (eBR), electronic work instructions, production execution, recipe management, material tracking, equipment integration, genealogy, traceability, and serialization.

•Designed and implemented MES integrations with ERP, PLC, SCADA, OPC UA, REST APIs, IoT devices, and shop-floor automation systems to support real-time manufacturing data exchange.

•Supported regulated manufacturing operations in compliance with GMP, GxP, GAMP 5, FDA 21 CFR Part 11, Computer System Validation (CSV), IQ/OQ/PQ, and CAPA requirements.

•Performed MES recipe, configuration, integration, and production issue troubleshooting, using SQL queries, MES event logs, manufacturing data, and system diagnostics for root-cause analysis.

•Developed SQL-based manufacturing reports and Power BI dashboards for production monitoring, manufacturing KPIs, OEE, and operational visibility.

•Gathered requirements from manufacturing, quality, validation, automation, IT, and business stakeholders and translated them into functional MES solutions and configuration specifications.

•Supported MES master data, recipe management, production configuration, release management, validation, deployment, production cutover, and post-production stabilization.

•Prepared and maintained Functional Specifications, Design Specifications, Configuration Specifications, validation documentation, deployment documentation, and change/release documentation.

Environment: Siemens OpsCenter (Camstar), SAP ME, Rockwell FactoryTalk, SAP S/4HANA, SQL Server, Oracle, C#, Java, SQL, REST APIs, OPC UA, PLC, SCADA, IIoT, Power BI, Azure DevOps, Git, Jenkins, Azure Cloud, Jira, Agile, Scrum.

Role: Senior MES Consultant Dec 2021 - May 2023

Client: Stellantis, Detroit, MI

Responsibilities:

•Led end-to-end MES solution design, implementation, configuration, integration, deployment, and production support across automotive manufacturing plants.

•Coordinated with manufacturing, quality, engineering, automation, and IT teams to translate business requirements into scalable MES solutions.

•Integrated MES with SAP ERP, PLCs, SCADA, OPC UA, historians, barcode scanners, RFID systems, vision systems, and shop-floor automation.

•Configured MES workflows supporting production execution, work orders, routing, genealogy, electronic work instructions, traceability, material consumption, labor reporting, and equipment integration.

•Supported Ignition SCADA integration and real-time shop-floor data exchange between automation systems and MES.

•Coordinated MES upgrades, patch deployments, release management, production cutover planning, and deployment activities with minimal production disruption.

•Worked closely with automation engineers to troubleshoot and resolve PLC, SCADA, MES, OPC, and shop-floor integration issues.

•Developed SQL queries, stored procedures, and database optimization solutions to improve MES application performance and manufacturing reporting.

•Supported production monitoring through OEE, KPI dashboards, downtime analysis, manufacturing reports, and real-time operational visibility.

•Performed root-cause analysis and coordinated corrective actions for MES production issues.

•Supported Windows Server, SQL Server, Oracle, IIS, Azure DevOps, Git, and Jenkins environments associated with MES applications.

•Participated in Agile/DevOps-based MES release, deployment, and continuous improvement activities.

Environment: Siemens OpsCenter (Camstar)/Apriso/SAP ME, Rockwell FactoryTalk, C#, .NET, ASP.NET, SQL Server, Oracle, SAP ERP, OPC UA, PLC, SCADA, Ignition, REST APIs, XML, Azure DevOps, Git, Jenkins, Windows Server, IIS

Role: Sr. MES Consultant Feb 2020 - Nov 2021

Client: Cardinal Health, Dublin, OH

Responsibilities:

•Designed and configured Electronic Batch Records (eBR), MES recipes, process instructions, production workflows, material genealogy, batch execution, and traceability for regulated manufacturing operations.

•Integrated MES with SAP ERP, LIMS, PLC/SCADA, historians, OPC, MQTT, and shop-floor automation systems to enable automated manufacturing data exchange.

•Supported MES validation and testing activities including SIT, FAT, UAT, CSV, GMP, GxP, GDP, FDA 21 CFR Part 11, CAPA, and production deployment.

•Managed MES master data including products, BOMs, resources, recipes, process parameters, equipment models, work centers, and production configurations.

•Developed SQL queries and manufacturing reports to analyze batch execution, equipment utilization, production performance, manufacturing quality, and operational KPIs.

•Performed root-cause analysis and troubleshooting across MES applications, recipes, databases, PLC/SCADA systems, OPC interfaces, and manufacturing integrations.

Environment: Siemens OpsCenter (Camstar) / Rockwell PharmaSuite, SAP ERP, SQL Server, Oracle, OPC, SCADA, PLC, ISA-95, Electronic Batch Records (EBR), FDA 21 CFR Part 11, GMP, GxP, CAPA, Agile, Azure DevOps, Git, Windows Server.

Role: MES Implementation Engineer Sep 2018 - Jan 2020

Client: Nestle Jacksonville, Illinois

Responsibilities:

•Designed and configured Electronic Batch Records (eBR), MES recipes, process instructions, electronic forms, material tracking, and production execution workflows.

•Integrated MES with SAP ECC, LIMS, historians, PLC, SCADA, and industrial automation systems using ISA-95 integration principles.

•Supported GMP, GAMP 5, FDA 21 CFR Part 11, Computer System Validation (CSV), audit trails, electronic approvals, deviation workflows, genealogy, and lot traceability.

•Gathered manufacturing requirements and translated business, quality, validation, engineering, and IT requirements into MES functional and configuration specifications.

•Performed MES troubleshooting, root-cause analysis, production issue resolution, validation, deployment, and continuous improvement.

Environment: Werum PAS-X, Rockwell PharmaSuite, SAP ECC, Syncade, ISA-95, EBR, GMP, GAMP 5, FDA 21 CFR Part 11, CSV, PLC, SCADA, SQL Server, Oracle, LIMS, Azure DevOps, Jira, Git, Agile.

Role: MES Engineer Jun 2016 - Aug 2018

Client: Mercedes-Benz,Altanta,GA

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Responsibilities:

•Supported MES-related manufacturing applications and enterprise integration solutions within a manufacturing environment.

•Developed and optimized SQL queries and stored procedures supporting manufacturing data processing and MES application performance.

•Developed and maintained REST APIs to facilitate integration between manufacturing and enterprise applications.

•Developed Python automation scripts supporting ETL, data processing, and manufacturing data integration.

•Supported troubleshooting and resolution of application and data-processing issues affecting manufacturing operations.

•Participated in Agile Scrum development, code reviews, version control, testing, deployment, and production support activities.

•Worked with SQL Server/MySQL, REST APIs, Python, Git, Jira, Unix/Linux, and enterprise application environments.

Environment: Python, Django/Flask (or specify the framework you used), SQL Server/MySQL, REST APIs, Git, Jira, Agile Scrum, Unit Testing, Unix/Linux.

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