CSV Engineer

Job Summary: CSV Consultant responsible for leading Computer System Validation (CSV) and applying Computer Software Assurance (CSA) principles for SAP S/4HANA with a focus on the Quality Management (QM) module. The role involves validation of QM processes, ensuring GxP compliance, managing QA/testing activities, and supporting regulatory and audit requirements in a regulated environment. Roles & Responsibilities: Lead Computer System Validation (CSV) for SAP S/4HANA (QM module focus). Apply Computer Software Assurance (CSA) principles to prioritize testing based on risk and criticality. Develop and review key documentation (URS, Risk Assessments, Test Scripts, Traceability Matrix, Validation Summary Reports). Streamline validation using CSA techniques such as unscripted testing, ad hoc testing, and risk-based test justification. Validate end-to-end QM processes including inspections, sampling, quality results, notifications, usage decisions, certificates, etc. Validate integrations across MM, PP, PM, EWM, and external systems (e.g., LIMS, MES). Ensure master data, configuration, and functional design meet GxP expectations. Define and manage test strategy, test planning, test execution, defect lifecycle, and QA gates. Ensure complete traceability from requirements through testing to release readiness. Support UAT and production deployment from a QA and compliance standpoint. Review and support investigation of Deviations related to system or process failures. Lead or oversee CAPA management, ensuring effective root cause analysis and follow-through. Review, assess, and approve Change Controls/Change Records, ensuring proper impact assessment and validation scope definition. Ensure all quality records are compliant, complete, and audit-ready. Ensure alignment with GxP, GAMP 5, 21 CFR Part 11, Annex 11, and data integrity (ALCOA+) requirements. Support internal/external audits and regulatory inspections as a CSV/CSA and SAP QM SME. Maintain rigorously controlled, audit-ready documentation. Partner with Business, IT, QA, and external vendors/implementation partners. Act as SME for SAP QM validation, testing, and compliance. Experience: Strong experience in CSV and CSA within regulated environments (Life Sciences/Pharma preferred). Deep understanding of SAP S/4HANA Quality Management processes. Hands-on experience with Deviations, CAPA, and Change Control management. Solid grasp of regulatory frameworks: GxP, GAMP 5, 21 CFR Part 11, Annex 11, and data integrity standards. Experience with QA/testing tools (Jira, Client ALM, Tosca, ADO, Cloud ALM). Strong communication, documentation, and stakeholder management abilities. Ability to work independently and collaboratively across cross-functional teams.