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 and 21 CFR Part 11 compliance
Familiarity with a risk-based validation approach
Strong communication and documentation skills
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 including 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
Full Job Description
Job Summary:
We are looking for a Computer System Validation (CSV) Engineer to support our client in Newark, DE. In this role, you will be responsible for ensuring that computerised systems used in regulated environments are validated and compliant with industry standards. You will work closely with IT, Quality, and business teams to support validation activities and maintain system compliance throughout its lifecycle.
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
