About The Role We are looking for a SAP Functional Subject Matter Expert (SME) with strong, 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) to ensure validation deliverables are complete, accurate, and audit-ready.

Support client audits and regulatory inspections by providing validation documentation, traceability, and subject-matter clarifications as needed.

Identify risks, gaps, and process improvement opportunities within SAP GxP landscapes and proactively recommend remediation or optimization approaches.

Mentor junior consultants and CSV analysts on SAP GxP concepts, validation methodology, and client engagement best practices.

Contribute to proposal development, effort estimation, and solutioning for new client opportunities involving SAP CSV/GxP scope.

Experience Qualifications Required 5–7 years of overall SAP functional experience, with a significant portion focused on Pharma/Life Sciences clients.

Hands-on experience with Computer System Validation (CSV) in a GxP-regulated environment — including authoring and executing IQ/OQ/PQ protocols, risk assessments, and validation summary reports.

Demonstrated functional experience with SAP GxP-relevant modules (e.g., QM, WM/EWM, PP, MM) in a validated/regulated context.

Practical experience with SAP ECC, and direct exposure to ECC to S/4HANA transformation projects (brownfield/greenfield/bluefield approaches,



data migration, and re-validation considerations).

Solid client-facing experience gained while working within a consulting, systems integrator, or IT/quality services organization — comfortable leading client discussions, workshops, and validation walkthroughs independently.

Working knowledge of applicable regulatory frameworks: 21 CFR Part 11, EU GMP Annex 11, data integrity (ALCOA+) principles, and GAMP 5 methodology.

Experience working within structured SDLC/validation lifecycle frameworks and quality management systems.

Prior experience supporting client audits or regulatory inspections is highly desirable.

Excellent communication, documentation, and stakeholder management skills, with the ability to work confidently across business, IT, and quality functions.

Educational Qualifications

Bachelor's degree in Engineering, Life Sciences, Pharmacy, Computer Science, Information Technology, or a related discipline (B.E./B.Tech/B.Pharm/B.Sc. or equivalent).

Master's degree (MBA, M.Pharm, or related) is a plus but not mandatory.

SAP functional certification (e.g., in QM, WM/EWM, PP, or MM) is preferred.

GAMP 5 or CSV-specific training/certification is an added advantage. Good to Have Exposure to SAP S/4HANA GxP validation approaches and differences from ECC-based validation.

Familiarity with electronic Quality Management Systems (eQMS) and their integration with SAP.

Experience working with global Pharma/Biotech clients across US/EU regulatory landscapes.

Awareness of emerging AI/automation trends in CSV and GxP computerized systems. This role is based out of Bangalore or Hyderabad, with flexibility considered for the right candidate. Some travel to client locations may be required.

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