Venkata Mahesh Patamsetty

About Venkata Mahesh Patamsetty

MES & Validation Engineer with 10+ years of experience delivering digital manufacturing solutions across pharma and medical device industries. Specialized in Aspen eBRS (MOC, MMDM, APRM), electronic batch record (eBR) implementation, and regulatory compliance (FDA 21 CFR Part 11, GAMP 5, ISA-95). Proven track record in replacing paper-based processes, improving batch execution efficiency, and ensuring data integrity across global manufacturing environments.Mechanical professional with a Master of Technology - M.Tech, from Visvesvaraya National Institute of Technology (VNIT Nagpur).

Experience

1. Mes Developer

   Tata Consultancy Services

   Jan 2021 — Present

   Deep knowledge of batch processing for MDPI and OSD products, including all manufacturing stages. Expertise in MDPI manufacturing (dispensing, blending, filling, assembly, packaging). Strong understanding of OSD processes such as granulation, compression, and coating. Led MES integration with plant operations to boost efficiency and compliance. Designed and implemented eBR systems using Aspen eBRS for MDPI and OSD production. Ensured eBR systems met GMP and FDA 21 CFR Part 11 compliance standards. Developed batch workflows to enhance automation, data integrity, and regulatory compliance. Created and validated Recipe Procedure Logic and Master Recipes in Aspen MOC. Troubleshot recipe execution issues and ensured process control compliance. Configured manufacturing data models in Aspen MMDM and maintained documentation. Optimized work order execution and analyzed production data using APRM and Batch Query Tool. Managed real-time data collection with Aspen IP.21 Historian and custom calculations. Administered user roles, security, and access control in Aspen Framework and ADSA tools. Led change management through ServiceNow and handled system deployment activities. Gaining proficiency in Power BI for data analytics and Azure Cloud for MES scalability.

Education

• Visvesvaraya National Institute of Technology (VNIT), Nagpur

  Master of Technology - MTech, Mechanical CAD/CM

• Aditya Educational Institutions

  Bachelor's degree, Mechanical Engineering

  2009 — 2013

• Visvesvaraya National Institute of Technology (VNIT), Nagpur

  Master's degree, CAD/CAM

• Visvesvaraya National Institute of Technology

  Master of Technology - MTech, Computer aided design and manufacturing

  2013 — 2015

• Visvesvaraya National Institute of Technology

  Master of Technology - MTech, Mechanical Engineering / CAD CAM