GxP CSV Engineer – Validation Lead for Lab Systems

Katalyst CRO; Columbus (OH); On-site; USD 80,000 - 100,000; Full time

Job summary

Katalyst CRO, located in Columbus, Ohio, is seeking a Validation Specialist to lead validation activities for GxP computerized systems, ensuring compliance with regulatory standards.

The ideal candidate will have a Bachelor's degree, significant experience in Computer System Validation, and knowledge of systems such as Veeva Vault QMS and BMRAM. This role ensures product quality, patient safety, and regulatory inspection readiness.

Qualifications

• 57+ years of experience in Computer System Validation (CSV) within a GxP regulated environment.
• Experience validating laboratory instrumentation or a building management system.
• Strong technical writing skills and ability to execute protocols with minimal supervision.

Responsibilities

• Author, review, and execute validation deliverables for GxP computerized systems.
• Perform risk assessments for validation approach and ensure appropriate testing.
• Manage system change control and deviations related to validated systems.

Skills

Technical writing

Computer System Validation (CSV)

Risk assessment

Data integrity principles (ALCOA+)

Collaboration with IT and QA

Education

Bachelor's degree in Computer Science, Engineering, Life Sciences, or equivalent experience

Tools

Veeva Vault QMS

BMRAM

HPLC

NetSuite

Job description

Katalyst CRO, located in Columbus, Ohio, is seeking a Validation Specialist to lead validation activities for GxP computerized systems, ensuring compliance with regulatory standards.

The ideal candidate will have a Bachelor's degree, significant experience in Computer System Validation, and knowledge of systems such as Veeva Vault QMS and BMRAM. This role ensures product quality, patient safety, and regulatory inspection readiness.