Advantage Technical ยท 16 hours ago
CSV Engineer
Austin, TX
Contract
Onsite
Mid Level
$50/hr - $55/hrAdvantage Technical is seeking a Computer System Validation Engineer to maintain and improve quality engineering programs. The role involves ensuring compliance with regulatory standards and leading CSV activities across software and IT systems.
Staffing & Recruiting
No H1B
Responsibilities
Define and implement validation strategy for the V&V program
Complete, review, and approve all CSV deliverables
Conduct assessments including Validation Applicability, 21CFRPart11, 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
Qualification
Required
Experience in computer system validation, software V&V, and regulatory compliance
Strong knowledge of 21CFRPart11, SOPs, and CSV documentation
Ability to conduct risk assessments and provide independent validation reviews
Excellent communication and training skills
Company
Advantage Technical
Advantage Technical aligns people and companies to create opportunity.
10001+ employees
Funding
Current Stage
Late StageCompany data provided by crunchbase