BRH Technical Configuration Lead

Role: BRH Technical Configuration Lead Location: Raritan, NJ Contract/Full-timeThe Batch Release Hub Technical Configuration Lead is responsible for the architecture, technical design, and hands-on configuration of the SAP S/4HANA-based Batch Release Hub (BRH) solution within the Johnson & Johnson enterprise SAP SAS (Serialization & Aggregation System) landscape. This role ensures the end-to-end technical integrity of batch disposition and release workflows across J&J's pharmaceutical manufacturing and supply chain operations, in compliance with FDA 21 CFR Part 11, EU Annex 11, and GxP standards.KEY RESPONSIBILITIES • Lead technical design and configuration of Batch Release Hub within SAP S/4HANA, including integration with QM, PP, WM/EWM, and SD modules. • Architect and configure batch classification, batch status management, and batch determination logic aligned to J&J release protocols. • Manage system integrations between SAP BRH, SAP SAS serialization platform, LIMS (LabWare/BIOVIA), and MES (Siemens Opcenter / Werum PAS-X). • Design and maintain technical specifications including FS/TS documents, interface design specs, data flow diagrams, and configuration workbooks. • Configure SAP workflows (SAP WS), output management, and electronic batch record (eBR) integration triggers. • Support GxP validation activities including IQ/OQ/PQ, 21 CFR Part 11 assessments, and computer system validation (CSV) documentation. • Collaborate with BASIS, security, and infrastructure teams on system landscape design, transport management (CTS+), and role/authorization framework. • Drive technical troubleshooting and root cause analysis for BRH system issues in production and validation environments. • Partner with functional leads to translate business requirements into robust technical solutions, gap analyses, and configuration decisions. • Support SAP upgrades, patch management, and regression testing for BRH components within the SAS platform. • Maintain technical documentation in compliance with J&J IT SDLC policies and Agile/hybrid delivery methodologies.REQUIRED QUALIFICATIONS •Education:Bachelor's degree in Computer Science, Information Systems, Engineering, or a related field. Master's degree preferred. •Experience:7+ years of SAP configuration experience, with at least 3 years directly on SAP QM and batch management in life sciences or pharmaceutical environments. •SAP S/4HANA:Hands-on configuration experience in SAP S/4HANA QM, PP-PI, and batch management; experience with SAP SAS or serialization modules strongly preferred. •GxP & Validation:Demonstrated knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5; experience writing CSV documentation (URS, FS, TS, IQ/OQ/PQ protocols). •Integration:Technical experience with SAP IDocs, BAPIs, ALE/EDI, REST/SOAP APIs, and middleware platforms (SAP PI/PO, CPI, MuleSoft) for system-to-system integration. •Serialization / SAS:Familiarity with SAP Advanced Track & Trace for Pharmaceuticals (ATTP) or equivalent serialization solutions in the J&J SAS ecosystem. •Transport & Landscape:Experience managing SAP transport requests across multi-tier landscapes (DEV/QAS/PRD); CTS+ and Solution Manager exposure preferred.PREFERRED QUALIFICATIONS • SAP Certified Application Associate – SAP S/4HANA Quality Management or equivalent. • Experience in a global life sciences company operating under FDA, EMA, or PMDA regulatory frameworks. • Knowledge of SAP Batch Where-Used, batch traceability reporting, and material ledger. • Familiarity with Agile/SAFe delivery frameworks and working in a scaled enterprise IT organization. • Experience with SAP Activate methodology for S/4HANA implementations and upgrades. • Exposure to J&J ONE ERP or equivalent large-scale global SAP transformation programs.TECHNICAL SKILLS SUMMARY •Core SAP:S/4HANA QM, PP-PI, WM/EWM, SD, Batch Management, Classification, Variant Configuration •SAS / Serialization:SAP ATTP, SAS Batch Release Hub, Track & Trace •Integration:SAP PI/PO, SAP CPI, IDocs, REST/SOAP, LIMS connectors, MES connectors •GxP Tools:SDLC, CSV, 21 CFR Part 11, GAMP 5, Validation Protocol authoring •Delivery:SAP Activate, Agile/SAFe, JIRA, ConfluenceRegards,Jagannath Gaddam jagannath.gaddam@quantumIntegrators.com