Rishab Potharla

MES Engineer specialising in Werum PAS-X v3.1.8, with 2.3 years of experience in Master Batch Record (MBR) design and MES L1 support across GxP-regulated pharmaceutical manufacturing environments. Experienced in taking MBRs through the full validation lifecycle from design and configuration through Unit Testing, SIT, and Go-Live ensuring batch records are production-ready before release. Brings proven ability to investigate and resolve real production incidents, including MO release failures, eBR execution exceptions on the shop floor, and material consistency errors, driving issues through to root cause and corrective action.

Underpinned by solid knowledge of 21 CFR Part 11, EU GMP Annex 11, GAMP5, ISA-95 standards, and SAP–MES data flows. Additionally holds an MSc in Blockchain Technology, with working knowledge of C#, JavaScript, and SQL that supports MES troubleshooting, database querying, and understanding system integration scripts during project delivery.

MES Engineer at Tata Consultancy Services (TCS) (2021-11 – 2024-01)

• Designed Master Batch Records (MBRs) in PAS-X, configuring Basic Operations (BOs) and defining functions and activities in line with validated manufacturing processes and GMP requirements.
• Managed MBR version upgrades through the change control process, ensuring QA sign-off was obtained before deploying updated batch records to production.
• Executed Unit Testing and System Integration Testing (SIT) on MBR configurations, documenting test results, logging deviations, and supporting Go-Live activities to ensure production-ready batch records.
• Delivered MES L1 support, responding to shop floor incidents including eBR execution exceptions, MO release failures, scale integration errors, etc., and coordinating resolution with technical teams within agreed SLAs.
• Configured and validated material master data received from ERP (SAP) as process orders into PAS-X, ensuring accurate L4 to L3 data flow and resolving ERP–MES interface issues to maintain uninterrupted production operations.
• Worked closely with Operations, Quality, and ERP teams to investigate cross-functional MES issues, ensuring data integrity across L4 to L3 system interactions in line with ISA-95 standards.
• Maintained MES configuration documentation, SOPs, and validation artefacts, ensuring full audit trail readiness for internal and external inspections in an FDA/HPRA-regulated environment.

Master of Science in Blockchain Technology & Its Applications – Atlantic Technological University (2024-01 – 2025-04)

Bachelor of Technology in Mechanical Engineering – CVR College of Engineering (2017-05 – 2021-04)