Computer System Validation (CSV) Lead - Oracle Fusion

No OPT/CPT

Job Summary

We are seeking an experienced Oracle Fusion Computer System Validation (CSV) Lead to support the implementation, validation, and ongoing lifecycle management of Oracle Fusion applications within a regulated life sciences environment.

The ideal candidate will have strong experience validating Oracle Fusion Cloud ERP applications, leading risk-based CSV/CSA activities, and ensuring compliance with 21 CFR Part 11, EU Annex 11, GAMP 5, data integrity, and applicable GxP requirements. The CSV Lead will work closely with Business, IT, Quality, Oracle implementation partners, and functional teams throughout the system implementation and deployment lifecycle.

Key Responsibilities

* Lead end-to-end Computer System Validation activities for Oracle Fusion Cloud ERP implementation, upgrades, integrations, and enhancements.
* Develop and maintain the overall Validation Strategy, Validation Plan, system risk assessments, and validation deliverables.
* Perform GxP Impact Assessment, System Risk Assessment, Data Integrity Assessment, and 21 CFR Part 11 / EU Annex 11 assessments.
* Review and approve User Requirements Specifications (URS), Functional Specifications, Configuration Specifications, and Design Specifications.
* Develop and execute risk-based IQ, OQ, PQ/UAT and functional testing for GxP-relevant Oracle Fusion functionality.
* Establish and maintain the Requirements Traceability Matrix (RTM) to ensure requirements are appropriately tested and documented.
* Review Oracle configuration and business processes to determine GxP criticality and validation requirements.
* Ensure appropriate testing of electronic records, electronic signatures, audit trails, security, role-based access, data integrity, and system controls.
* Support validation of interfaces between Oracle Fusion and systems such as LIMS, MES, QMS, WMS, manufacturing applications, banking systems, and other enterprise platforms.
* Lead validation activities associated with legacy data migration into Oracle Fusion, including migration strategy, mapping, reconciliation, completeness, accuracy, and migration verification.
* Review and approve test scripts, test evidence, deviations, defects, and associated remediation activities.
* Coordinate validation activities with Oracle functional consultants, technical teams, business process owners, Quality Assurance, IT, and third-party implementation partners.
* Ensure appropriate controls are established for Oracle roles, privileges, Segregation of Duties (SoD), user access, and security administration.
* Lead validation activities for system changes through established change control and configuration management processes.
* Support investigation and resolution of validation discrepancies, defects, deviations, and CAPAs.
* Prepare and approve Test Summary Reports and Validation Summary Reports prior to production release.
* Support system release management, go-live readiness, cutover, hypercare, and post-production validation activities.
* Maintain the validated state of Oracle Fusion through periodic reviews, change controls, incident management, upgrades, patches, and regression testing.
* Provide CSV/CSA guidance to project teams using a risk-based approach consistent with FDA Computer Software Assurance principles.
* Support internal audits, regulatory inspections, and inspection-readiness activities related to Oracle Fusion.

Oracle Fusion Modules

Experience validating several of the following modules is preferred:

* Financials
    * General Ledger (GL)
    * Accounts Payable (AP)
    * Accounts Receivable (AR)
    * Fixed Assets
    * Cash Management
* Supply Chain Management (SCM)
    * Procurement
    * Purchasing
    * Inventory Management
    * Order Management
    * Product Information Management
* Manufacturing
    * Manufacturing
    * Work Execution
    * Bills of Material
    * Work Definitions
    * Production Scheduling
* Quality Management
    * Quality Inspection
    * Quality Issues
    * Quality Actions
    * Nonconformance-related processes
* Planning
    * Supply Planning
    * Demand Management
    * Material Planning

Required Qualifications

* Bachelor’s degree in Engineering, Computer Science, Information Systems, Life Sciences, or related discipline.
* Strong experience in Computer System Validation within pharmaceutical, biotechnology, medical device, or other FDA-regulated environments.
* Hands-on validation experience with Oracle Fusion Cloud ERP / Oracle Cloud Applications.
* Experience leading CSV activities for large-scale ERP implementations, migrations, or transformation programs.
* Strong knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, ALCOA+, cGMP, and data integrity principles.
* Experience preparing and reviewing validation deliverables including:
    * Validation Plan
    * GxP Assessment
    * Risk Assessment
    * URS
    * Functional/Configuration Specifications
    * IQ/OQ/PQ/UAT
    * Part 11 Assessment
    * Data Integrity Assessment
    * Data Migration Plan/Report
    * RTM
    * Test Summary Report
    * Validation Summary Report
* Strong understanding of ERP data migration, interfaces, security, roles, audit trails, and master data controls.
* Experience working with Agile, Waterfall, V-Model, and risk-based CSA/CSV methodologies.
* Ability to work directly with Business, Quality, IT, implementation partners, and senior project stakeholders.

Preferred Qualifications

* Previous experience with Oracle Fusion implementation or migration from legacy ERP platforms such as Oracle EBS, SAP, JD Edwards, or Microsoft Dynamics.
* Experience validating Oracle integrations using APIs, middleware, or enterprise integration platforms.
* Experience with validation management/test management tools such as ValGenesis, Kneat, HP ALM, Jira, Xray, or similar platforms.
* Strong documentation, communication, leadership, and stakeholder-management skills.