AG Solution Group

Editor

• Author, configure, and maintain master recipes and electronic batch records within Siemens Opcenter Pharma, ensuring full alignment with approved manufacturing procedures and regulatory requirements.
• Translate process descriptions, SOPs, and paper-based MBRs into structured, ISA-88-compliant digital recipes, including procedural elements, phase logic, process parameters, and material allocations.
• Collaborate with process development, manufacturing, QA, and automation teams to gather requirements, validate recipe logic, and obtain the necessary approvals through the change control process.
• Perform recipe testing and verification in non-production environments, supporting UAT and ensuring that executed batch records meet GxP expectations before go-live.
• Maintain recipe versioning and lifecycle management in accordance with site change control SOPs and the capabilities of the Opcenter Pharma recipe management module.
• Support integration touchpoints between Opcenter Pharma and adjacent systems including SAP (PP/PI/QM), historians, SCADA/DCS layers, and laboratory systems (LIMS), ensuring consistent material, parameter, and status data flows.
• Identify and implement improvements to recipe templates, phase libraries, and reusable building blocks to reduce authoring time and increase recipe consistency across product families.
• Participate in validation activities (IQ/OQ/PQ, CSV), contributing to test scripts, traceability matrices, and deviation investigations related to recipe execution.
• Act as a subject matter expert during audits and regulatory inspections, providing clear documentation and rationale for recipe design decisions.
• Mentor junior recipe authors and provide training to super-users and shop-floor personnel on recipe execution and EBR interaction.

Recipe Editor – Pharma