Lead I - Engineering Design - MBR Designer

Responsibilities

• Core Deliverables as MBR / ESP Designer Parameterization Structure : Defining {}Characteristics (CX){}, which remain editable within the MBR/ESP environment 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

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