Job Description

Urgent Hiring for Computer System Validation (CSV) Specialist

Position: Computer System Validation (CSV) Specialist

Location: San Diego, CA (Onsite)

Duration: 4+ Months Contract

Position Summary

Our medical device client in the San Diego area is seeking an experienced Computer System Validation (CSV) Specialist to ensure computerized systems used in regulated environments meet all applicable standards and regulatory requirements, including FDA 21 CFR Part 11 & 820, Data Integrity, ISO 13485, and GAMP 5 . The specialist will develop and execute validation protocols, risk assessments, and documentation supporting the lifecycle of cGxP systems.

Key Responsibilities

• Develop, review, and execute test plans, test cases, and test scripts across multiple projects.
• Schedule and perform system qualification and validation activities .
• Draft and review User Requirement Specifications (URS) and Software Design Specifications (SDS) .
• Generate and maintain regulated documentation including change orders, test reports, SOPs, PFMEA, and forms .
• Participate in project meetings and coordinate validation deliverables.
• Perform manual and automated testing , identify and track defects to resolution.
• Conduct root-cause analysis and support developers during issue investigation.
• Utilize SQL for queries (SELECT, JOIN, and execution).
• Ensure all activities comply with FDA cGxP , company policies, and industry best practices.

Qualifications

• Bachelor’s degree or higher in Engineering, Life Sciences, or a related field.
• 7+ years of relevant experience in FDA-regulated industries (medical devices, pharma, biotech).
• Strong knowledge of 21 CFR Part 11, Part 820, Data Integrity, ISO 13485, ISA 95, and GAMP 5 .
• 5+ years of hands-on experience in Computerized Systems Validation and SQL-based testing .
• Familiarity with web reports, test scripts, and database validation .
• Excellent technical writing, documentation, and analytical skills.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint).
• Experience with document control and issue tracking systems such as:
• Oracle Agile, ValGenesis, JAMA (document control)
• Jira, Bugzilla (issue tracking)
• Understanding of Software Development Life Cycle (SDLC) principles.

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