Notes from HM: We have some flexibility with MES - FTPS skill set/ FactoryTalk PharmaSuite experience preferred; however, candidates with any MES experience in Life Sciences environments will be considered
• System Design & Configuration: Develop, deploy, and maintain Rockwell FactoryTalk PharmaSuite (FTPS) and FTPC MES applications.
• EBR Authoring: Design, configure, and validate Electronic Batch Records (EBR) to enforce manufacturing workflows.
• Integrations: Integrate MES solutions with ERP systems (e.g., SAP) and plant-floor control equipment/SCADA systems.
• Troubleshooting: Debug system defects, resolve data gaps, and perform unit testing before production deployments.
• Compliance: Ensure all system architectures adhere to 21 CFR Part 11, GAMP, and cGMP regulatory standards within validated environments.
Technical Requirements
• Platform Expertise: Hands-on development experience with Rockwell FactoryTalk PharmaSuite (FTPS).
• Database & APIs: Advanced SQL, database management, and RESTful API or webservices development.
• Life Sciences Domain: Deep working knowledge of Good Manufacturing Practices (GMP) and Software Development Life Cycle (SDLC) methodologies.