Design and architect end-to-end PAS-X MES solutions. Gather business requirements and translate them into scalable MES designs. Configure EBR, Materials Management, Weighing & Dispensing, Equipment Management, Traceability, and Workflow Management. Define integrations with SAP, LIMS, QMS, Historian, SCADA, and Warehouse systems. Ensure compliance with GxP, FDA 21 CFR Part 11, Annex 11, and GAMP5. Support validation activities including URS, FS, DS, IQ/OQ/PQ. Lead client workshops, architecture reviews, estimations, and project governance. Mentor teams and provide technical leadership.
Additional Responsibilities:
Experience in PAS-X V3 migration and multi-site rollouts preferred. Exposure to cloud platforms such as Azure or AWS. Bachelor's degree in Engineering, Computer Science, Life Sciences, or related field. Experience Level: Senior Architect / Principal Consultant. Industry: Pharmaceutical, Biotech, Cell & Gene Therapy, and Life Sciences Manufacturing.
Technical and Professional Requirements:
10+ years of MES implementation experience. 5+ years of hands-on Körber PAS-X architecture and implementation experience. Expertise in PAS-X Workflow Designer, Material Management, Interface Framework, and Intelligence/KPI. Strong knowledge of pharmaceutical manufacturing processes. Experience with SAP ECC/S4HANA, SAP ATTP, SAP EWM, LIMS, QMS, and Historian systems. Integration expertise using REST, SOAP, IDocs, BAPIs, XML, JSON, SQL, CPI, MuleSoft, or Boomi. Knowledge of ISA-95 and ISA-88 standards.
Sql, Sap Ecc, Soap, Idocs, S4hana, Bapis, Json, Boomi, Mulesoft, Sap Ewm, Xml, REST, K rber PAS X MES, Lims, ISA 88, PAS X Workflow Designer, Historian systems, SAP ATTP, ISA 95, Intelligence KPI, cpi, Qms, Material Management Interface Framework
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