Computer Systems Validation Expert

Title: Computer SystemsValidation Expert

End Client - Moderna

The Role:(Summary)

We are seeking an experienced Computer Systems Validation (CSV) Expert to lead qualification and validation activities for the ServiceNow Change Management implementation. ServiceNow is an existing Category 1 IT Service Management (ITSM) / Workflow Platform, and this role will support a risk-based qualification approach focused on the GxP-relevant Change Management workflow and supporting platform controls rather than requalification of the entire ServiceNow platform. The CSV Expert will work with the ITSM Change Management Process Owner, ServiceNow Platform Owner, Digital Compliance, QA, infrastructure and technical SMEs, and applicable ServiceNow/implementation vendors to ensure that the solution is appropriately specified, configured, verified, traceable, released, and maintained in a compliant state.

Key Responsibilities of the Position:

·Provide lead CSV support for the ServiceNow Change Management implementation, coordinating validation activities with the ITSM Change Management Process Owner, ServiceNow Platform Owner, QA/Digital Compliance, technical SMEs, infrastructure teams, and applicable vendors.

·Define and document the risk-based qualification strategy in the Qualification Plan (QP), including scope, assumptions, leveraged evidence, roles and responsibilities, required deliverables, verification approach, acceptance criteria, release requirements, and any justified exclusions.

·Support and maintain alignment between the governing Veeva Change Request and the ServiceNow Infrastructure Change Request (ICR), ensuring qualification deliverables, implementation activities, testing, discrepancies, and release evidence are appropriately referenced and controlled.

·Lead or facilitate development and review of the Requirements Specification (RS), ensuring Change Management business/process requirements, technical requirements, security/access requirements, integration requirements, CMDB dependencies, and non-functional requirements are clear, testable, risk-assessed, and traceable.

·Coordinate the classification-based risk assessment for the Category 1 ITSM / Workflow Platform implementation, ensuring risk is assessed at the requirement/control level and drives the required verification rigor.

·Review the Configuration / Design Specification (CS/DS) to confirm that the documented ServiceNow configuration and design adequately implement the approved requirements and identified risk controls, including workflows, state transitions, approvals, roles, permissions, notifications, auditability, CMDB dependencies, and relevant integrations.

·Develop, review, and/or support execution of Installation Qualification in the validation environment [IQ (VAL)], Operational Qualification (OQ), and Installation Qualification in the production environment [IQ (PROD)] in accordance with the approved qualification strategy.

·Ensure OQ coverage verifies the in-scope Change Management workflow and controls, including applicable change types, risk/impact assessment, GxP-relevant processing, approvals, scheduling, implementation controls, emergency change processing, closure, role-based access, audit history, notifications, and other controls identified as critical by the RS and risk assessment.

·Ensure objective evidence is captured contemporaneously during test execution and that test executors are appropriately trained and qualified on applicable procedures and protocols.

·Create and maintain the Traceability Matrix (TM) linking requirements and risk controls to configuration/design and qualification testing, and verify that all in-scope requirements are appropriately covered prior to release.

·Review and assess discrepancies, deviations, anomalies, and test failures identified during qualification; ensure they are formally documented, investigated, risk-assessed, resolved, and re-tested or re-verified as appropriate before release.

·Evaluate and document the suitability of existing ServiceNow platform qualification evidence and supplier/vendor documentation proposed for leverage, ensuring only unchanged and applicable evidence is relied upon and that any gaps are addressed through additional Moderna verification.

·Support identification and review of impacted SOPs and operational procedures, including Change Management process procedures and ServiceNow system administration/technical procedures, to ensure operational readiness at release.

·Prepare or coordinate the Qualification Summary Report (QSR), summarizing the qualification approach, deliverable status, risk assessment outcomes, testing results, discrepancies and resolutions, residual risks, acceptance criteria, and fitness for intended use.

·Ensure all qualification documentation and evidence are complete, consistent, inspection-ready, and stored in the dedicated ServiceNow folder under the IT Infrastructure location in Kneat in accordance with the approved document structure and retention requirements.

Required Background:

·Bachelor's Degree in Life Sciences, Information Technology, Engineering, or a related field

·Minimum 5 years of relevant job experience in a regulated (GxP) environment

·5+ years of job-related experience in Computer 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

Project-Specific Experience Preferred:

·Hands-on CSV/qualification experience with ServiceNow or comparable enterprise ITSM / workflow platforms in a regulated GxP environment.

·Experience qualifying configured workflows such as IT Change Management, Incident Management, access/security workflows, or other GxP-relevant ITSM processes.

·Demonstrated experience with Category 1 / infrastructure qualification approaches, including Qualification Plans, Requirements Specifications, Configuration / Design Specifications, IQ/OQ protocols, Traceability Matrices, and Qualification Summary Reports.

·Strong understanding of risk-based validation and the ability to distinguish platform-level controls from project-specific GxP-relevant workflows so that existing evidence can be appropriately leveraged without over-validating the platform.

·Experience working with controlled document and protocol systems such as Kneat and quality change-control systems such as Veeva is highly desirable.

·Ability to work across business process ownership, platform ownership, Digital Compliance/CSV, QA, infrastructure, and vendor teams and to translate business process intent into clear, testable validation requirements.