CSV Engineer

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

Job Description

The CSV Engineer is responsible for ensuring that GxP computerized systems at the client site are validated in compliance with regulatory standards (21 CFR Part 11, EU Annex 11, GAMP 5). This role directly supports gene therapy manufacturing operations by leading validation activities for key systems, including Veeva QMS, BMRAM, analytical lab instruments, and the Metasys Client. By maintaining data integrity and system compliance, the CSV Engineer plays a critical part in ensuring product quality, patient safety, and regulatory inspection readiness.

Roles & Responsibilities

• Author, review, and execute validation deliverables for GxP computerized systems, including Validation Plans, Requirements Specifications (URS/FS/DS), IQ/OQ/PQ protocols, Trace Matrices, and Validation Summary Reports.
• Support computer system validation efforts for Veeva Vault QMS, BMRAM (laboratory information management), analytical lab instruments (e.g., HPLC, UHPLC, PCR instruments, plate readers etc.), ERP System (NetSuite).
• Perform risk assessments to determine validation approach and ensure appropriate testing of system functionality, data integrity, and audit trail review.
• Manage system change control, deviations, and CAPAs related to validated systems, ensuring compliance with Forge's quality system.
• Collaborate with IT, QA, Lab Operations, and Facilities teams to support system upgrades, patches, and periodic reviews while maintaining a validated state.

Requirements

• Bachelor's degree in Computer Science, Engineering, Life Sciences, or related field (or equivalent experience).
• 57+ years of experience in Computer System Validation (CSV) within a GxP regulated environment (pharmaceutical, biotech, or medical device).
• Working knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, and data integrity principles (ALCOA+).
• Experience validating at least one of the following: Veeva Vault QMS, BMRAM, laboratory instrumentation (e.g., Waters, Agilent, Chromeleon, Softmax or similar), or a building management system (Client) like Metasys.
• Strong technical writing skills and ability to execute protocols with minimal supervision.
• Nice to have: BMRAM and analytical lab instruments experience.