Senior Computer Systems Validation Expert

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

Summary

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

Roles & 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.
• Develop, articulate, and gain stakeholder alignment on pragmatic, risk-based validation strategies that are right-sized to system impact and complexity.
• Document and implement approved validation strategies, ensuring scope, roles/responsibilities (including vendor) and deliverables are clearly defined and executed.
• Provide lead validation support and coordinate risk assessments for system functionality and data flows, identifying critical control points and residual risks.
• Provide lead validation support for User Requirements Specification (URS) / functional requirement definition and ensure that requirements are clear, testable, and traceable.
• 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.
• Draft key validation deliverables and ensure they are clear and complete prior to review/approval routing: Specifications, DRA, Risk Assessments, Validation Protocols, Data Migration, Traceability Matrix, Validation Summary Report.
• Ensure documentation, issues/discrepancy logs, and validation evidence are inspection-ready.

Education & 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
• Experience leading CSV for digital projects within Manufacturing and supply chain processes