CSV Engineer

Katalyst CRO; Newark (DE); On-site; USD 80,000 - 100,000; Full time

Job summary

Katalyst CRO is seeking a Computer System Validation (CSV) Engineer to support our client in Newark, DE. You will lead validation activities for computerized systems in regulated environments, ensuring compliance with FDA standards and GAMP 5 guidelines. The role requires a Bachelor's degree in a relevant field and experience in a GxP setting. Strong documentation and communication skills are essential. Join us to help maintain system compliance throughout the lifecycle.

Qualifications

• 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.

Responsibilities

• Lead and support CSV activities for GxP systems, including validation planning, execution, and reporting.
• Develop and review validation deliverables such as Validation Plans and protocols.
• Ensure compliance with FDA 21 CFR Part 11 and GAMP 5 guidelines.

Skills

Computer System Validation

GxP Compliance

Documentation Skills

Communication Skills

Education

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

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.
• Familiarity with a risk-based validation approach.
• Strong communication and documentation skills.