CSV Engineer
Katalyst CRO · Newark, DE · 2 mo ago
On-siteEngineeringContract
Job Summary
We are looking for a Computer System Validation (CSV) Engineer to support our client in Newark, DE.
Roles & Responsibilities
- Lead and support CSV activities for GxP systems, including validation planning, execution, and reporting
- Develop and review validation deliverables such as Validation Plans, URS, FS/DS, IQ, OQ, PQ protocols, and summary reports
- Ensure compliance with FDA 21 CFR Part 11, 21 CFR Part 820, and GAMP 5 guidelines
- Perform risk assessments to determine validation scope and testing requirements
- Support system implementation, upgrades, and changes through change control processes
- Collaborate with cross-functional teams (IT, QA, Validation, and business users)
- Maintain and review validation documentation to ensure accuracy and completeness
- Participate in audit readiness activities and support regulatory inspections
- Identify and resolve validation deviations, discrepancies, and non-conformances
- Ensure proper data integrity and security compliance across systems
Education & Experience
- Bachelor's degree in Computer Science, Engineering, Life Sciences, or related field
- Experience in Computer System Validation in a GxP environment
- Strong understanding of CSV lifecycle and validation documentation
- Hands-on experience with GAMP 5, 21 CFR Part 11 compliance
- Familiarity with a risk-based validation approach
- Strong communication and documentation skills