GxP CSV Validation Lead for Regulated Systems

Katalyst CRO; Seattle (WA); On-site; USD 80,000 - 110,000; Full time

Job summary

Katalyst CRO is looking for a CSV Engineer in Seattle to ensure GxP computerized systems are validated in compliance with regulatory standards. The role involves leading validation activities for key systems, maintaining data integrity, and supporting manufacturing operations.

Ideal candidates will have a Bachelor's degree in a relevant field and significant experience in Computer System Validation within a regulated environment. This position directly supports gene therapy and ensures regulatory readiness.

Qualifications

• 57+ years of experience in Computer System Validation (CSV) within a GxP regulated environment.
• Working knowledge of GAMP 5, 21 CFR Part 11, and EU Annex 11.
• Strong technical writing skills and ability to execute protocols with minimal supervision.

Responsibilities

• Author and execute validation deliverables for GxP computerized systems.
• Support computer system validation for various systems, including Veeva Vault QMS.
• Perform risk assessments to determine validation approaches.

Skills

Computer System Validation

Technical writing

GxP compliance

Data integrity

Education

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

Tools

Veeva Vault QMS

BMRAM

HPLC

NetSuite

Job description

Katalyst CRO is looking for a CSV Engineer in Seattle to ensure GxP computerized systems are validated in compliance with regulatory standards. The role involves leading validation activities for key systems, maintaining data integrity, and supporting manufacturing operations.

Ideal candidates will have a Bachelor's degree in a relevant field and significant experience in Computer System Validation within a regulated environment. This position directly supports gene therapy and ensures regulatory readiness.