Application Programming Interface (API), Biology, Code of Federal Regulations, Current Good Manufacturing Practice (cGMP), Database Administration, Debugging Skills, ERP (Enterprise Resource Planning), FTP (File Transfer Protocol), GMP (Good Manufacturing Practices), Manufacturing, REST (Representational State Transfer), Regulations, SAP, SQL Databases, Software Development Lifecycle (SDLC), Supervisory Control and Data Acquisition (SCADA), System Architecture, Systems Administration/Management, Testing, Unit Test, Web Programming, Web Services
Job Description:
• 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 web services development.
• Life Sciences Domain: Deep working knowledge of Good Manufacturing Practices (GMP) and Software Development Life Cycle (SDLC) methodologies.