CSV Engineer

Position: Computer System Validation Engineer

Location: Austin, TX

Contract: 6 months

Hours: 8–5 (flexible as needed)

Rate: $50–$55/hr

No C2C or agency referrals

Maintain and improve quality engineering programs, ensuring compliance with regulatory standards and company policies. Lead and support computer system validation (CSV) activities across software and IT systems.

• Define and implement validation strategy for the V&V program.
• Complete, review, and approve all CSV deliverables.
• Conduct assessments including Validation Applicability, 21
  
  CFRPart
  11, and Software Functionality Risk Assessments.
• Review test cases, executed protocols, and reports to ensure proper coverage and compliance with validation standards.
• Provide guidance on incident/defect handling and risk mitigation.
• Review and update SOPs, templates, and validation documentation.
• Support internal and external audits.
• Develop and maintain quality standards, inspection/testing procedures, and corrective actions.
• Compile and report quality data; liaise with Product Engineers, Quality Program Managers, and regulatory bodies as needed.

• Experience in computer system validation, software V&V, and regulatory compliance.
• Strong knowledge of 21
  
  CFRPart
  11, SOPs, and CSV documentation.
• Ability to conduct risk assessments and provide independent validation reviews.
• Excellent communication and training skills.