CSV Engineer

Advantage Technical; Austin (TX); On-site; USD 68,880 - 75,768; Full time

Job summary

A leading technical staffing firm is seeking a Computer System Validation Engineer in Austin, Texas. The role involves maintaining and improving quality engineering programs while ensuring compliance with industry standards. Key responsibilities include defining validation strategies, reviewing documentation, and conducting risk assessments. Candidates should have experience in computer system validation and strong communication skills. This is a 6-month contract position with a pay rate of $50–$55 per hour.

Qualifications

• Experience in computer system validation, especially in regulated industries.
• Strong knowledge of 21CFRPart11 and validation documentation.
• Proven ability to conduct risk assessments.

Responsibilities

• Define and implement validation strategies for the validation program.
• Conduct assessments and ensure compliance with validation standards.
• Review and approve all CSV deliverables and documentation.

Skills

Computer system validation

Regulatory compliance

Risk assessments

SOP documentation

Communication skills

Job description

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

Role Overview

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.

Key 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.

Qualifications

• 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.