• Execute CSV activities for SAP implementation, enhancement, upgrade, integration, and support projects. • Participate in validation planning and determine validation requirements based on system criticality, intended use, GxP impact, and risk. • Support preparation, review, and approval of validation deliverables such as: • Validation Plan / Master Validation Plan inputs. • GxP and system impact assessments. • Computerized System Risk Assessments. • User Requirements Specifications (URS). • Functional and Design Specifications, where applicable. • Requirements Traceability Matrix (RTM). • Test plans, test scripts, test protocols, and test evidence. • Installation, Operational, and Performance Qualification documentation, where applicable. • Validation Summary Reports. • Standard Operating Procedures and Work Instructions. • Review SAP business and functional requirements to ensure applicable GxP, quality, regulatory, and data integrity requirements are adequately addressed. • Ensure requirements are clear, testable, traceable, and appropriately linked to business and regulatory risks. • Support risk-based validation and testing strategies to avoid unnecessary testing while ensuring adequate control of GxP-critical functionality. • Review SAP configuration, custom developments, workflows, reports, forms, interfaces, conversions, enhancements, and integrations from a CSV/GxP perspective. • Participate in SAP testing activities including: • Functional testing. • System Integration Testing (SIT). • User Acceptance Testing (UAT). • Regression testing. • GxP/validation testing. • Review executed test evidence for completeness, accuracy, traceability, objective evidence, and compliance with validation procedures. • Ensure test deviations, incidents, and defects are documented, investigated, resolved, and appropriately assessed for GxP impact. • Support validation of SAP interfaces with external or third-party applications and ensure appropriate controls for data transfer, reconciliation, error handling, and audit trail. • Assess and document data integrity controls including ALCOA+ principles, audit trails, electronic records, electronic signatures, access controls, and record retention. • Support evaluation of SAP roles, authorization controls, segregation of duties, and privileged access where relevant to GxP processes. • Participate in SAP data migration validation including source-to-target mapping, data verification, reconciliation, completeness, and accuracy checks. • Support assessment and validation of SAP master data and transactional data impacting regulated business processes. • Participate in validation of applicable SAP modules/processes such as: • Materials Management (MM). • Production Planning (PP). • Quality Management (QM). • Plant Maintenance / Asset Management (PM/EAM). • Extended Warehouse Management (EWM). • Finance and Controlling where GxP relevance exists. • SAP Fiori applications and workflows. • SAP integrations and interfaces. • Work with SAP functional and technical teams to ensure validation requirements are embedded throughout the system development lifecycle. • Support change controls and perform GxP/validation impact assessments for SAP enhancements, configuration changes, patches, upgrades, and releases. • Support periodic reviews of validated SAP systems to confirm continued validated state. • Support incident, problem, deviation, CAPA, and change-management processes affecting validated systems. • Assist in maintaining validation documentation throughout the system lifecycle and ensure controlled documentation is current and audit ready. • Support system decommissioning and archival activities where required. • Participate in internal audits, regulatory inspections, customer audits, and supplier audits involving computerized systems. • Provide validation documentation and evidence during inspections and respond to auditor/inspector queries as required. • Ensure validation activities comply with organizational SOPs, Quality Management System requirements, and approved project methodology. • Coordinate with Quality Assurance for review and approval of validation documents and resolution of compliance observations. • Support qualification and assessment of SAP vendors, System Integrators, cloud/service providers, and third-party technology suppliers where applicable. • Promote standardized CSV practices and consistent validation methodology across SAP projects and geographical locations. • Identify validation risks early and escalate gaps that may impact regulatory compliance, data integrity, testing, or project go-live readiness. Required Experience & Skills • Minimum 8+ years of overall IT/CSV/SAP experience, preferably within pharmaceutical, biotechnology, medical device, healthcare, or other regulated industries. • Strong hands-on experience in Computerized System Validation for SAP systems. • Practical understanding of SAP implementation and application lifecycle activities. • Experience supporting at least one full SAP implementation, upgrade, rollout, or major transformation program preferred. • Good understanding of pharmaceutical GxP business processes and associated computerized-system controls. • Working knowledge of applicable regulations and guidance, including: • US FDA 21 CFR Part 11. • EU GMP Annex 11. • GAMP 5 principles and risk-based validation. • Data Integrity / ALCOA+ principles. • Applicable GxP and Good Documentation Practices. • Experience preparing and reviewing validation lifecycle documentation. • Hands-on experience with risk assessment, requirements management, traceability, testing, deviation management, and validation reporting. • Good understanding of SAP configuration versus custom development and associated validation risks. • Understanding of SAP interfaces, data migration, security, authorization, audit trails, and master-data controls. • Experience with validation/document management tools such as ValGenesis, Kneat, OpenText, HP ALM, Jira, SAP Cloud ALM, Solution Manager, or equivalent is desirable. • Ability to interpret technical and functional SAP documentation from a regulatory and quality perspective. • Strong analytical and documentation skills with attention to accuracy, traceability, and compliance. • Ability to work effectively with business, Quality Assurance, IT, SAP functional/technical teams, System Integrators, and external vendors. • Good communication, stakeholder-management, and problem-solving skills. • Ability to manage multiple validation deliverables and priorities within project timelines. • Any bachelor's or master's degree from a recognized institution. • SAP certification in any relevant functional or technical area is preferred but not mandatory. • CSV, GAMP 5, Quality, ISPE, or regulatory compliance certification is advantageous. • Experience with SAP S/4HANA, particularly Cloud Private Edition or large-scale global SAP transformation programs, is preferred. • Experience in pharmaceutical manufacturing, quality, warehouse, supply chain, laboratory, or regulated business processes is desirable.