BRH Technical Configuration Lead

Role: BRH Technical Configuration Lead

Location: Raritan, NJ (Onsite)

Full-time with Quantim Integrators (W2 Contract will work)

The 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, Confluence

Regards,

Jagannath Gaddam