cGMP Validation, Oracle EBS Quality Assurance Analyst

Leidos

. Lead and support cGMP computerized-system validation activities for Oracle EBS applications and enhancements .

Posted 9/29/2026full-timeRemote • United StatesMid-LevelSenior💰 $59,150 - $106,925 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in cGMP computerized-system validation, including developing validation plans, test protocols, and documentation for Oracle EBS applications. Proficient in Agile methodologies and compliance with regulatory standards such as 21 CFR Part 11.

Highest-signal resume keywords

CGMP Computerized-System ValidationOracle E-Business Suite (EBS) TestingValidation Plans and Protocols DevelopmentFunctional and User Acceptance TestingRegulatory Compliance (21 CFR Part 11)

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Applicant Tracking System Keywords

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Hard Skills

Computerized-System ValidationTest Protocol DevelopmentRequirements TraceabilityTest Case DevelopmentDefect Tracking and DocumentationAgile MethodologiesValidation Evidence DocumentationRegression TestingIntegration TestingUser Acceptance Testing

Soft Skills

Analytical SkillsCommunication SkillsOrganizational SkillsCollaboration SkillsProblem-Solving Skills

Tools & Technologies

Oracle EBSAutomated Testing ToolsTest Management ToolsOracle Cloud Infrastructure (OCI)

Certifications & Qualifications

Public Trust Clearance Eligibility

Industry Keywords

CGMP21 CFR Part 11FDA-Regulated EnvironmentsPharmaceuticalMedical DevicePublic HealthChange ControlAgile/SAFe DeliveryHHS EPLC

Tech Stack

Tools & technologies

CloudOracle

About the role

Key responsibilities & impact

Lead and support cGMP computerized-system validation activities for Oracle EBS applications and enhancements
Develop and maintain validation plans, requirements traceability, test protocols/scripts, validation evidence, deviation records, and validation summary documentation
Ensure system changes comply with applicable cGMP, 21 CFR Part 11, SNS change-control, and validation requirements
Integrate validation activities and evidence into Agile development iterations and release processes
Review requirements, user stories, acceptance criteria, functional designs, configurations, and changes for testability and validation impact
Develop and execute test plans, scenarios, scripts, and cases for Oracle EBS functional, integration, regression, and user acceptance testing
Document test results, defects, deviations, corrective actions, and retesting evidence
Validate Oracle EBS changes across inventory, warehouse, supply-chain, asset-management, and financial processes
Coordinate validation and testing with functional analysts, developers, DBAs, infrastructure engineers, business users, and Government stakeholders
Support release-readiness reviews and verify required validation and testing evidence before production implementation
Maintain validation and QA documentation in accordance with configuration and document-control requirements
Support audits, assessments, and requests for validation evidence
Participate in Agile planning, refinement, demonstrations, and retrospectives as appropriate
Support critical system issues and emergency-response activities as required by the SNS mission
Acknowledge critical incidents within 15 minutes while on call

Requirements

What you’ll need

5+ years of experience in computerized-system validation, software quality assurance/testing, or related regulated-system activities, including substantial cGMP validation experience
Demonstrated experience with cGMP computerized-system validation in a regulated environment
Working knowledge of 21 CFR Part 11 and validation/change-control principles
Experience developing validation plans, protocols, traceability matrices, test scripts, validation evidence, deviation documentation, and summary reports
Experience testing Oracle E-Business Suite (EBS) applications
Experience with functional, integration, regression, and user acceptance testing
Experience translating requirements, user stories, and acceptance criteria into executable test scenarios and scripts
Experience documenting, tracking, retesting, and closing defects and validation deviations
Strong documentation, analytical, communication, and organizational skills
Ability to work effectively with business, functional, development, infrastructure, and Government stakeholders
Ability to obtain and maintain the required Tier 2 background investigation/security eligibility
Ability to comply with HHS/ASPR/SNS security and training requirements
Ability to participate in 24x7 on-call support and respond to mission alerts within required timeframes
Preferred: Experience validating Oracle EBS R12 applications
Preferred: Experience supporting Oracle EBS supply-chain, inventory, warehouse, asset-management, or financial modules
Preferred: Experience with FDA-regulated, pharmaceutical, medical-device, medical-supply, public-health, or other cGMP environments
Preferred: Experience incorporating validation evidence into Agile/SAFe delivery
Preferred: Experience with automated testing or test-management tools
Preferred: Experience with Oracle EBS hosted in Oracle Cloud Infrastructure (OCI)
Preferred: Familiarity with HHS EPLC or other federal system-development/governance frameworks
Must be a US Citizen or Green Card holder with the ability to obtain a Public Trust Clearance

Benefits

Comp & perks

Remote work arrangement
Participation in 24x7 on-call services
Opportunity to support mission-critical public-health and emergency-response systems