CSV Engineer

Katalyst CRO; Newark (DE); Presencial; USD 85.000 - 120.000; Jornada completa

Descripción de la vacante

Katalyst CRO is seeking a Computer System Validation (CSV) Engineer to support our client in Newark, DE. This role ensures 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. Responsibilities include leading CSV activities for GxP systems, developing validation deliverables (Validation Plans, URS,

Formación

• 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.

Responsabilidades

• 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

Conocimientos

CSV lifecycle

Regulatory compliance

Documentation skills

Cross-functional collaboration

GxP experience

Educación

Bachelor's degree in Computer Science, Engineering, Life Sciences, or related field

Herramientas

GAMP 5

Validation protocols

Descripción del empleo

• 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.


• 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

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


• Familiarity with a risk-based validation approach


• Strong communication and documentation skills