Job Description

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

• Education: 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 .

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