Key Responsibilities:
Design and configure MBR/ESP structures, including Characteristics (CX) and Custom Attributes (CA) .
Develop reusable Process Value Libraries for processes such as mixing, autoclaving, and manual washing.
Design GMBRs and PMBRs for product families and specific formulations.
Perform Level 2 / Automation Mapping between MES and SCADA, PLC, DCS systems for bidirectional data exchange.
Configure Material Flow & Equipment Tracking Rules , including material dosing, container tracking, weighing/dispensing, and room/equipment states.
Prepare/contribute to Functional Requirement Specifications (FRS) and translate paper-based processes into PAS-X .
Develop Recipe Design Specifications covering formulas, tolerances, interlocks, and process logic.
Create Testing & Operational Qualification (OQ) scripts to validate correct/incorrect operator inputs and system behavior.
Ensure all designs and documentation comply with GxP/regulated setting requirements.