Description

Lead the design and configuration of Electronic Batch Records (EBR) within the PharmaSuite MES environment.

Responsibilities

• Create business process flow diagrams for pharmaceutical product recipes based on paper batch records or source documents.
• Gather site-specific requirements to develop User Requirement Specifications (URS) and Functional Requirement Specifications (FRS).
• Break down manufacturing processes logically to configure recipes in MES and develop reusable EBR design elements and workflows.
• Integrate MES with SAP and other automation systems using standard MBR design interface components.
• Lead recipe design sessions with SMEs, produce solution design and configuration documents, and assist with business SOPs.

Required Skills

• 11+ years of experience in MES implementation and configuration.
• Expertise in MES PharmaSuite.
• Deep knowledge of EBR design for Biotech, Gene Therapy, Vaccine Manufacturing, or Packaging processes.
• Ability to gather master data and configure it across Development, Quality, and Production environments.
• Experience designing equipment workflows and status diagrams based on business process flows.
• Strong capability in translating source documents into digital manufacturing workflows.

Key Skills

Education

Any Gradute