SAP CSV Consultant

Position: SAP CSV Expert

Location: Boston MA

Contract Based

Summary

We are seeking an experienced Computer Systems Validation expert to lead validation and testing for ERP platform (S/4, BTP, MDG). This is a critical role in ensuring that the system functions as designed and as per regulatory expectations. Candidate will be working with a cross-functional team including Digital, QC, QA, infrastructure, and other vendors.

Responsibilities:

• Lead validation support for large-scale, cross-functional initiatives, ensuring alignment across Business, Digital, and Quality stakeholders.
• Partner with Business and Digital teams to develop a deep understanding of end-to-end business processes, system functionality, and data flows.
• Provide lead validation support for the change control process, ensuring impact assessment, risk-based validation approach, and maintenance of validated state.
• Ensure traceability from requirements through testing.
• Ensure that all personnel involved in validation activities — whether internal staff or external partners — are appropriately trained and qualified in applicable test execution procedures and protocols.
• Monitor and document test execution to ensure objective evidence is captured contemporaneously.
• Review and assess all discrepancies, deviations or anomalies identified during validation or subsequent operation, ensuring each is formally documented, investigated, and subject to root cause analysis. Verify implementation and effectiveness of corrective and preventive actions (CAPA), including re-testing or re-verification as appropriate, to confirm restoration of validated state and compliance with GxP requirements.

Required Experience:

• Minimum 10 years of relevant job experience in a regulated (GxP) environment
• Minimum 10 years of CSV experience within SAP system validation
• Experience with Regulatory standards and deliverables
• Proven track record in CSV with a strong understanding of CSV/SDLC practices
• Excellent problem-solving, communication, and documentation skills
• Experience validating AI solutions in a GMP environment