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Sage ERP Technical SME
Remote, RemoteRole Overview
The Sage ERP Technical SME (Life Sciences) owns the technical architecture, validation, compliance, and integration of our Sage X3 ecosystem. You will align complex biochemical manufacturing, formula management, and global regulatory compliance with system architecture, data integrity, and strict traceability standards.
Key Responsibilities
The Sage ERP Technical SME (Life Sciences) owns the technical architecture, validation, compliance, and integration of our Sage X3 ecosystem. You will align complex biochemical manufacturing, formula management, and global regulatory compliance with system architecture, data integrity, and strict traceability standards.
Key Responsibilities
- Formula & Batch Optimization: Configure and optimize Safe-X3 (4GL) scripts, work orders, and routings to manage chemical formulas, batch processing, and material potency.
- Traceability & Compliance: Build custom workflows to automate end-to-end lot tracing, shelf-life management, expiration alerts, and strict quality control gating.
- System Validation: Author and execute technical validation protocols (IQ/OQ/PQ) to maintain alignment with life science standards (e.g., FDA 21 CFR Part 11, GMP, and EU Annex 11).
- Multi-Legislation Integration: Manage localization folders, tax compliance setups, and multi-currency reporting structures across international divisions.
- Secure API Architecture: Develop and maintain REST/SOAP web services linking Sage X3 to specialized third-party systems, including LIMS, MES, and WMS.
- Reporting & Intelligence: Design highly auditable data views, Crystal Reports, and Sage Enterprise Intelligence (SEI) dashboards for regulatory inspections and yield metrics.
- Experience: Minimum 5+ years of Sage X3 technical development experience within an agile life sciences, chemical, or biotech environment.
- Compliance Knowledge: Direct technical exposure to regulatory frameworks, automated audit trails, electronic signatures, and computerized system validation (CSV).
- Programming & DB: Mastery of Safe-X3 development language, SQL Server scripting, indexing, database profiling, and secure data pipelines.
- Supply Chain Logic: Clear understanding of catch-weight management, hazardous material storage logic, and manufacturing yield calculations.