Sr. Software Engineer - FactoryTalk PharmaSuite Job

Role Overview

We are looking for an experienced Rockwell FactoryTalk PharmaSuite (FTPS) MES Engineer with strong handson expertise in Master Recipe development using Recipe Designer, recipe and workflow configuration, and Electronic Batch Record (EBR) implementation in regulated pharmaceutical manufacturing environments.

The ideal candidate will have practical experience working on PharmaSuite MES systems, supporting recipe lifecycle management, batch execution workflows, and ensuring compliance with 21 CFR Part 11 and GxP requirements.

Experience

5-6 Years

Key Responsibilities

• 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.

Required Skills & Experience :

• 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.

Preferred / Good to Have :

• Exposure to PharmaSuite version upgrades and multisite deployments.
• Experience working in global pharma manufacturing environments.
• Understanding of integration with PLC/SCADA systems (Rockwell Automation).
• Prior audit or regulatory inspection support experience.