Core Deliverables as MBR / ESP Designer* *Parameterization Structure :* Defining {*}Characteristics (CX){*}, which remain editable within the MBR/ESP setting for flexibility, and {*}Custom Attributes (CA){*}, which are fixed parameters pulled from global master data. *Process Value Libraries :* Developing standardized, reusable building blocks for specific processes (e.g., mixing, autoclaving, manual washing). *Generic and Product Master Batch Records (GMBRs / PMBRs):* Building the high-level graphical structures of recipes. GMBRs group similar product families together to maximize efficiency, while PMBRs represent specific product formulations. *Level 2 / Automation Mapping:* Establishing the data exchange points between the MES and Level 2 automation (e.g., SCADA, PLC, DCS systems) to enable direct bidirectional communication with shop floor equipment. {*}Material Flow & Equipment Tracking Rules:{*}Mapping the logic for material dosing, container status tracking,



weighing and dispensing workflows, and room/equipment state controls within the specific area. *Documentation Deliverables:* As it is a regulated GxP environment, the designer delivers or contributes to: {*}Functional Requirement Specifications:{*}Mapping how the paper-based process translates into a digital PAS-X format. *Recipe Design Specifications:* Explaining the mathematical formulas, tolerances, and interlocks built into the ESP design. {*}Testing & Operational Qualification Scripts:{*}Creating formalized verification steps to prove the system handles correct and incorrect operator inputs exactly as configured
PAS-X MES, GxP, Requirements Gathering, Manufacturing Execution Systems, Asset Management, PLC Programming, DCS, Functional Testing, IQ/OQ/PQ, SCADA, Supply Chain Management

📌 Lead I (Bengaluru)
🏢 UST
📍 Bengaluru