CSV Engineer
Kasmo Global
CSV Engineer
We are seeking a CSV (Computer System Validation) Engineer with experience in the medical device industry for a long-term onsite contract role in Vernon Hills, IL. The ideal candidate will have a solid understanding of CSV processes, FDA 21 CFR Part 11 compliance, and validation documentation. This role requires hands-on experience with validation activities, ensuring compliance with regulatory requirements, and supporting software validation efforts.
Key responsibilities include:
- Develop and execute Computer System Validation (CSV) protocols, including IQ, OQ, and PQ.
- Ensure compliance with FDA 21 CFR Part 11, GxP regulations, and industry best practices.
- Support validation efforts related to software applications used in a medical device environment.
- Create and review validation documentation, including validation plans, test scripts, and reports.
- Work closely with cross-functional teams, including Quality Assurance, Regulatory, and IT, to ensure compliance with validation requirements.
- Conduct risk assessments and impact analyses for software and computerized systems.
- Support audits and regulatory inspections related to computer system validation.
- Troubleshoot and resolve validation-related issues, providing recommendations for process improvements.
Qualifications:
- Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related field.
- 3+ years of experience in Computer System Validation within the medical device or pharmaceutical industry.
- Strong knowledge of FDA 21 CFR Part 11, GAMP 5, and other relevant regulations.
- Experience with validation of software applications and computerized systems.
- Understanding of quality systems and regulatory requirements in the medical device industry.
- Excellent documentation and technical writing skills.
- Ability to work onsite in Vernon Hills, IL.
Preferred qualifications:
- Experience with Part 11 validation of software applications.
- Knowledge of risk-based validation approaches.
- Strong problem-solving skills and attention to detail.
Vacancy posted 21 hours ago
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