GxP CSV Engineer — Validation Lead

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

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.