Computer System Validation Specialist

Job Description

Computer System Validation Specialist

Location : Oceanside, California

Long Term Project

Key Responsibilities

• Validation Protocol Development & Execution
• Develop, author, and execute Software Test Protocols to verify system functionality and compliance.
• Draft, route, and execute Commissioning and Qualification Protocols (CQ, IQ, OQ, PQ), including comprehensive final reports.
• Perform end-to-end validation lifecycle activities, from planning through approval and closeout.
• System Qualification & Data Analysis
• Plan, schedule, and execute qualification activities to support system readiness.
• Collect, analyze, and interpret qualification data against acceptance criteria.
• Identify and document deviations, discrepancies, and resolutions to ensure compliance.
• Documentation & Compliance Oversight
• Draft, review, and maintain key documents, including User Requirement Specifications (URS), Software Requirement Specifications (SRS), Software Design Specifications (SDS), SOPs, PFMEA, and validation forms .
• Ensure compliance with cGMP, GDP, and FDA cGxP regulatory standards , incorporating risk-based approaches.
• Support the creation and update of procedures and best practices related to system validation and data integrity.
• Project & Audit Support
• Actively participate in project meetings, providing status updates and ensuring alignment with timelines.
• Coordinate with cross-functional stakeholders to support system implementation and compliance readiness.
• Prepare and present validation documentation for internal and external audits / inspections , ensuring audit readiness at all times.

Qualifications & Requirements