Computer System Validation Specialist Job at Staftonic LLC, Oceanside, CA

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  • Staftonic LLC
  • Oceanside, CA

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 .

Job Tags

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