Senior CSV Lead: ERP Validation & GMP Compliance

Katalyst-Healthcares-; Norwood (MA); On-site; USD 150,000 - 190,000; Full time

Job summary

JobDiva, Inc. in Norwood, MA seeks an experienced Computer Systems Validation expert to lead validation for the Moderna ERP platform (S/4, BTP, MDG). You will coordinate cross-functional teams to ensure regulatory expectations and robust validation across the lifecycle.

The successful candidate will have 10+ years in GxP CSV, deep SAP validation expertise, and a proven track record in risk-based validation, traceability, and CAPA within manufacturing and supply chain projects.

Qualifications

• Minimum 10 years of relevant CSV experience in a regulated environment.
• Minimum 10 years of CSV experience within SAP system validation.
• Experience with Regulatory standards and deliverables.
• Proven track record in CSV/SDLC practices.
• Excellent problem-solving, communication, and documentation skills.
• Experience validating AI solutions in a GMP environment.
• Experience leading CSV for digital projects within Manufacturing and supply chain processes.

Responsibilities

• Lead validation support for large-scale, cross-functional initiatives.
• Partner with Business and Digital teams to understand end-to-end processes, system functionality, and data flows.
• Provide lead validation support for change control processes, risk-based validation, and validated state maintenance.
• Develop, articulate, and gain stakeholder alignment on pragmatic validation strategies.
• Document and implement approved validation strategies, ensuring scope, roles/responsibilities, and deliverables are defined.
• Provide risk assessments for system functionality and data flows, identify critical control points and residual risks.
• Provide lead validation support for URS / functional requirement definition and ensure requirements are clear, testable, and traceable.
• Ensure traceability from requirements through testing.
• Ensure personnel involved are trained and qualified in test execution procedures.
• Monitor and document test execution to capture objective evidence.
• Review and assess discrepancies, deviations, or anomalies with root-cause analysis and CAPA verification.
• Draft key validation deliverables: Specifications, DRA, Risk Assessments, Protocols, Data Migration, Traceability Matrix, Validation Summary Report.
• Ensure documentation and validation evidence are inspection-ready.

Skills

Validation leadership

GxP compliance

Regulatory standards

Documentation skills

Risk-based validation

Traceability

CAPA management

SAP validation

Tools

SAP S/4HANA

SAP MDG

SAP BTP

Job description

JobDiva, Inc. in Norwood, MA seeks an experienced Computer Systems Validation expert to lead validation for the Moderna ERP platform (S/4, BTP, MDG). You will coordinate cross-functional teams to ensure regulatory expectations and robust validation across the lifecycle.

The successful candidate will have 10+ years in GxP CSV, deep SAP validation expertise, and a proven track record in risk-based validation, traceability, and CAPA within manufacturing and supply chain projects.