FactoryTalk PharmaSuite

Job Describtion:

Exp:5+ Yrs

Location:Hyd,Pune,Indore,Bangalore.

FactoryTalk PharmaSuite - MES Engineer

• FactoryTalk PharmaSuite & Recipe Management
• Design, develop, and maintain Master Recipes using FactoryTalk PharmaSuite Recipe Designer.
• Configure recipe workflows, including Unit Procedures, Operations, and Phases, aligned with ISA88 standards.
• Develop and enhance PharmaSuite MES building blocks for manufacturing and packaging processes.
• Implement and support Electronic Batch Records (EBR) within PharmaSuite.
• Manage recipe versioning, approvals, controlled deployment, and change management.
• Import and validate recipes across Development, Stage, and Production environments.
• MES Configuration & Execution
• Configure Production Execution Client, Production Management Client, and Data Manager components.
• Model equipment hierarchies (classes, entities, properties), Work Centers, and Workstations.
• Author and test material operations, including Weigh & Dispense and packaging workflows.
• Support batch execution, exception handling, and workflow optimization.
• Validation & Compliance
• Ensure MES configurations comply with 21 CFR Part 11, GAMP 5, and data integrity (ALCOA+) principles.
• Contribute to URS, FRS, IQ, and OQ activities related to MES and recipe workflows.
• Prepare validation evidence, test scripts, and configuration documentation.
• Support audits, inspections, and periodic reviews.
• Support & Continuous Improvement
• Troubleshoot recipe execution issues, EBR failures, and workflow deviations.
• Support PharmaSuite upgrades and regression testing of recipes and workflows.
• Collaborate with QA, Automation, Manufacturing, and IT teams.

• 5+ years of handson experience with FactoryTalk PharmaSuite (FTPS) in pharma or lifesciences environments.
• Strong experience in Master Recipe development using Recipe Designer.
• Practical knowledge of recipe and workflow development in PharmaSuite MES.
• Experience with EBR configuration and batch execution workflows.
• Solid understanding of ISA88 batch standards.
• Working knowledge of 21 CFR Part 11, GxP, and data integrity requirements.
• Experience preparing or supporting IQ/OQ and validation documentation.
• Familiarity with SQL Server and MES data handling.
• Good communication and stakeholdercoordination skills.