Design, develop, and maintain Master Recipes using FactoryTalk PharmaSuite Recipe Designer.
Configure recipe workflows, including Unit Procedures, Operations, and Phases, aligned with ISA‑88 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.
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.
Ensure MES configurations comply with 21 CFR Part 11, GAMP 5, and data integrity (ALCOA+) principles.
Prepare validation evidence, test scripts, and configuration documentation.
Support audits, inspections, and periodic reviews.
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 hands‑on experience with FactoryTalk PharmaSuite (FTPS) in pharma or life‑sciences 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 ISA‑88 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 stakeholder‑coordination skills.

Senior Software Engineer – FactoryTalk PharmaSuite

Key skills