Rockwell PharmaSuite (MES)
SRINIVAS REDDY
MES Implementation Lead | PharmaSuite | Digital Manufacturing | CSV & GxP
Visakhapatnam,AP
Summary
- MES professional with 14+ years in pharmaceutical manufacturing and 5+ years of hands-on experience in Rockwell PharmaSuite (FTPS) implementation, configuration, and live plant support within GMP-regulated OSD environments. Strong expertise in:
- Electronic Batch Records (EBR / eBMR) design and execution
- MES workflow configuration and master recipe (MBR) authoring
- SAP–MES integration (iDOC-based process flows)
- Equipment integration and shopfloor system connectivity
- Validation lifecycle (URS, FDS, IQ, OQ, PQ) aligned with GAMP 5
- Troubleshooting and stabilizing MES in live manufacturing environments Combines deep shop-floor understanding with MES system ownership to deliver compliant, reliable digital manufacturing solutions.
Overview
15
15
years of professional experience
Work History
MES SME – Master Recipe Authoring & Compliance
Eisai Pharmaceuticals India Pvt. Ltd.
01.2025 - Current
- Leading lifecycle management of master recipes and MES workflows in PharmaSuite
- Driving updates and enhancements based on CAPA, change controls, and process improvements
- Designing and configuring workflows for new product introductions and new manufacturing areas
- Owning MES governance, change control, and compliance documentation
- Investigating MES-related deviations and supporting CAPA implementation
- Ensuring data integrity and audit readiness aligned with GMP, ALCOA+, and 21 CFR Part 11
- Improving workflow robustness and reducing execution issues through structured enhancements
MES Implementation Lead – PharmaSuite (FTPS) Project
Eisai Pharmaceuticals India Pvt. Ltd.
04.2021 - 12.2024
- Led end-to-end implementation of Rockwell PharmaSuite MES across OSD manufacturing operations
- Designed and configured EBRs and workflows aligned with real shop-floor processes
- Delivered SAP–MES integration via iDOCs for process order execution, material movements, and traceability
- Integrated weighing systems using MOXA-based communication for real-time data capture and audit compliance
- Executed full validation lifecycle (URS → FDS → IQ → OQ → PQ) in line with GAMP 5 and GxP
- Led testing, troubleshooting, and issue resolution across MES workflows and integrations
- Supported go-live, hypercare, and system stabilization in a live manufacturing environment
- Optimized project cost through hybrid integration strategy using existing infrastructure
- Trained 80+ users across Production, QA, IT, and Engineering on MES execution and exception handling
- Coordinated cross-functional teams to ensure smooth deployment and adoption
Documentation Specialist – Manufacturing
Eisai Pharmaceuticals India Pvt. Ltd.
04.2019 - 03.2021
- Managed Batch Manufacturing Records (BMR) and Batch Packing Records (BPR)
- Supported deviation investigations, SOP revisions, and compliance documentation
- Contributed to transition from paper-based records to electronic batch records
Production & Packaging (Granulation / Compression / Coating / Packing)
Eisai Pharmaceuticals India Pvt. Ltd.
11.2011 - 03.2019
- Hands-on experience across full OSD manufacturing lifecycle
- Led dispensing and material planning activities
- Supported process improvements and equipment operations
- Built strong process understanding that later supported MES configuration and design
Education
Bachelor of Pharmacy - B.Pharm
Andhra University
Skills
Rockwell PharmaSuite (FTPS) — EBR, workflows, master recipe authoring
Electronic Batch Records (EBR / eBMR)
MES Workflow Configuration & MBR Design
SAP PP-PI Integration (iDOC / process orders / confirmations)
Shopfloor Integration (weighing systems, PLC interfaces)
Equipment Integration (Mettler Toledo, Sartorius, Precisa, MOXA gateways)
Accomplishments
- Delivered full PharmaSuite MES implementation across OSD manufacturing — design, configuration, validation, and stabilization
- Enabled SAP–MES integration for seamless batch execution and traceability
- Reduced integration cost significantly through hybrid balance integration strategy (MOXA + existing infrastructure)
- Trained 80+ cross-functional users, enabling smooth go-live and reducing hypercare load
- Bridged shop-floor operations with MES system design, improving usability and adoption
Software
SAP PP-PI (Process Orders, BOM, Master Data Integration)
TrackWise (QMS)
MOXA Gateway Integration
SCADA / PLC Interface Understanding
OPC / OPC-UA Concepts
Microsoft Excel (Data Analysis, Reporting)
Microsoft PowerPoint (Technical Presentations)
Microsoft Word (GxP Documentation)
Timeline
MES SME – Master Recipe Authoring & Compliance
Eisai Pharmaceuticals India Pvt. Ltd.
01.2025 - Current
MES Implementation Lead – PharmaSuite (FTPS) Project
Eisai Pharmaceuticals India Pvt. Ltd.
04.2021 - 12.2024
Documentation Specialist – Manufacturing
Eisai Pharmaceuticals India Pvt. Ltd.
04.2019 - 03.2021
Production & Packaging (Granulation / Compression / Coating / Packing)
Eisai Pharmaceuticals India Pvt. Ltd.
11.2011 - 03.2019
Bachelor of Pharmacy - B.Pharm
Andhra University
ADDITIONAL INFORMATION
- Open to relocation
- Notice Period: 90 days
- Comfortable working in onsite, plant-based MES environments
Professional Highlights
- Led end-to-end implementation of Rockwell PharmaSuite MES for oral solid dosage manufacturing, covering dispensing to packing workflows
- Executed SAP–MES integration using IDOC/BAPI for process orders, BOM, and production execution alignment
- Reduced hardware integration cost from ₹95L to ₹40L using hybrid balance integration with MOXA gateways
- Designed and validated eBMR workflows compliant with 21 CFR Part 11 and ALCOA+ principles
- Conducted MES training and hypercare support for 80+ shopfloor and QA personnel