SAP ERP Functional & Validation SME — Pharma / Life Sciences

Experience: 5–8 Years

Location: Hyderabad — Hybrid, Willing to Travel atleast 50%

Function: SAP Consulting, CSV and GxP Compliance

Industry: Pharmaceuticals and Life Sciences

About The Role We are looking for a confident and hands-on SAP ERP Functional and Validation SME with strong experience in pharmaceutical or life sciences environments.

The candidate should have practical knowledge of SAP ECC, SAP S/4HANA and the wider SAP ecosystem, along with strong experience in Computer System Validation, SAP documentation, testing and training.

This is not a documentation-only CSV role. The person must understand how SAP business processes are designed, configured, integrated, tested, validated, deployed and maintained.

Key Responsibilities

• Act as the SAP Functional SME for GxP-regulated SAP programmes involving ECC, S/4HANA and related SAP applications.
• Provide functional expertise in at least two modules such as QM, MM, PP/PP-PI, WM/EWM, SD or PM/EAM.
• Understand end-to-end SAP processes across procurement, manufacturing, quality, warehousing, distribution and maintenance.
• Review requirements, process designs and SAP configurations for business and compliance suitability.
• Support SAP implementation, rollout, upgrade, carve-out and ECC-to-S/4HANA transformation programmes.
• Participate in fit-gap, fit-to-standard, process-design and validation workshops.
• Assess GxP impact and define revalidation strategies for ECC-to-S/4HANA migrations.
• Review SAP standard functionality, configuration, custom developments, interfaces, reports, forms and security controls.
• Prepare and review SAP documentation, including:
• Business process and functional design documents.
• Configuration specifications and workbooks.
• WRICEF or RICEFW inventories.
• Interface and data-migration specifications.
• Role and authorisation matrices.
• Cutover, deployment and operating procedures.
• Lead CSV activities, including:
• Validation plans.
• GxP assessments.
• URS and functional specifications.
• Risk assessments.
• IQ, OQ, UAT and PQ protocols.
• Traceability matrices.
• Validation summary reports.
• Ensure compliance with 21 CFR Part 11, EU GMP Annex 11, GAMP 5 and ALCOA+ principles.
• Define and review unit, integration, regression, OQ, UAT and PQ testing.
• Support defect assessment, retesting and GxP impact evaluation.
• Validate SAP data migration, interfaces and integrations with MES, LIMS, QMS, eQMS and WMS.
• Develop and deliver SAP ECC and S/4HANA training for business users, key users and support teams.
• Create training plans, user guides, SOPs, work instructions, job aids and train-the-trainer materials.
• Independently lead client workshops, process walkthroughs and validation reviews.
• Challenge unclear requirements, weak controls and unnecessary customisation.
• Support client audits and regulatory inspections.
• Mentor junior consultants and contribute to proposals, estimation and solution design.

Required Experience And Skills

• 5–8 years of SAP ERP consulting, implementation, validation or support experience.
• Strong experience within pharmaceutical, biotechnology, medical-device or regulated life sciences environments.
• Functional expertise in at least two SAP modules, preferably QM, MM, PP/PP-PI, WM/EWM, SD or PM/EAM.
• Practical experience with SAP ECC.
• Exposure to at least one SAP S/4HANA implementation, conversion, rollout or assessment.
• Hands-on experience with SAP functional, configuration, testing and validation documentation.
• Experience with SAP data migration, integrations, testing and change control.
• Experience developing and delivering SAP user training.
• Strong understanding of CSV, GAMP 5, Annex 11, 21 CFR Part 11 and data integrity.
• Strong client-facing, documentation, communication and stakeholder-management skills.
• Bachelor’s degree in Engineering, Pharmacy, Life Sciences, Computer Science, IT or a related discipline.

Mandatory Certification

• The candidate must hold at least one valid SAP certification relevant to the role.
• Preferred areas include SAP S/4HANA, QM, MM, PP/PP-PI, EWM, SD, PM/EAM or SAP Activate.

Behavioural Expectations

The Candidate Should Be

• Confident, bold and assertive in client discussions.
• Comfortable challenging incomplete requirements and poor design decisions.
• Decisive and able to provide clear recommendations.
• Structured, accountable and detail-oriented.
• Pragmatic in balancing compliance with business needs.
• Capable of independently leading SAP functional and validation workstreams.

Good to Have

• Experience with SAP Fiori, SAP BTP, SAP Integration Suite, SAP Solution Manager, SAP Cloud ALM, SAP GRC or SAP Signavio.
• Experience with global SAP rollouts, carve-outs or acquisitions.
• Familiarity with Computer Software Assurance and automated testing.
• Awareness of AI and automation opportunities in SAP validation and documentation.