Computer System Validation Specialist
Staftonic LLCOceanside, CA, US1 day ago
Job type
- Full-time
Job descriptionEducation : Bachelor’s degree in Engineering, Life Sciences, Computer Science, or related discipline (advanced degree preferred). Experience : Minimum 7+ years of Computer System Validation (CSV) experience in FDA-regulated environments (pharmaceutical, biotechnology, or medical devices). Regulatory Expertise : Strong, working knowledge of 21 CFR Part 11, 21 CFR Part 820, ISO 13485, GAMP 5, and Data Integrity principles . Technical Skills : Hands-on experience in authoring and executing validation protocols, test scripts, and system lifecycle documentation . At least 5+ years of SQL experience for data mining, system testing, and report validation. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, MS Project, Visio) for technical writing and reporting. Soft Skills : Exceptional technical writing, documentation review, and analytical abilities . Strong organizational and communication skills with the ability to collaborate across departments. Demonstrated ability to work independently in a fast-paced, regulated environment .
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
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Validation Specialist • Oceanside, CA, US