About The Role

We are looking for a SAP Functional Subject Matter Expert (SME) with robust, hands-on experience in Computer System Validation (CSV) within regulated Pharma/Life Sciences environments. The ideal candidate has worked extensively on SAP GxP modules, understands both SAP ECC and the transformation journey to S/4HANA, and has a proven track record of client-facing delivery as part of a consulting or IT services organization. This role sits at the intersection of SAP functional expertise and quality/compliance rigor — you'll be the trusted bridge between business, IT, and quality teams on regulated SAP implementations.

Responsibilities

Serve as the SAP Functional SME for engagements involving GxP-regulated SAP modules, ensuring solutions meet both business requirements and applicable regulatory expectations (GMP, GDP, and related GxP standards).
Lead and support Computer System Validation (CSV) activities across the SAP implementation lifecycle — including URS, functional/design specifications, risk assessments, IQ/OQ/PQ protocols, traceability matrices,



and validation summary reports.
Provide functional expertise on SAP GxP-relevant modules (e.g., QM, WM/EWM, PP, MM, and related GxP-configured processes), ensuring configurations align with validated-state requirements.
Support and lead SAP ECC to S/4HANA transformation projects — including gap analysis, fit-gap assessments, data migration validation, and re-validation strategy for GxP processes moving from ECC to HANA.
Partner directly with client stakeholders — business process owners, IT teams, and Quality/Compliance functions — to gather requirements, design solutions, and drive consensus on validation approach.
Author and review key CSV/GxP deliverables in line with client SOPs, 21 CFR Part 11, Annex 11, and other applicable data integrity and computerized systems regulations.
Collaborate with cross-functional project teams (functional consultants, technical/ABAP teams, testers, and quality leads)

📌 SAP Functional SME — Pharma CSV (Bengaluru)
🏢 eMonkGlobal
📍 Bengaluru