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 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.
- 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 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.
