JD:
• Create business process flow diagrams for pharmaceutical product recipes based on the paper batch record or source documents.
• Gather MES site-specific requirement analysis to develop URS and FRS.
• Logically breakdown the recipes/Mfg. process to configure the recipe into MES.
• Develop/create EBR design elements (building blocks) and workflows in MES for repetitive use in EBR creation to expedite the process.
• Experience with EBR design for Biotech, Gene Therapy, Vaccine Manufacturing, and Packaging processes in Pharma.
• Gather master data and configure in MES Development/Quality/Production Environment.
• Integrate MES with SAP and other automation systems using standard interface components of MBR design.
• Lead the recipe design session with business process SMEs.
• Design EBR/recipe, equipment workflow/status diagram based on the business process flow.
• Create solution design and configuration documents.
• Prepare key user training documents and impart key user training.
• Provide assistance in business SOP creation.
Top Skills:
1. MES Pharmasuite
2. EBR design
3. MES product hands-on experience for full application configurations including interface with SAP and automation systems