CSV Engineer

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

Job Summary

• Ensure GxP computerized systems at the client site are validated in compliance with regulatory standards (21 CFR Part 11, EU Annex 11, GAMP 5).
• Lead validation activities for key systems supporting gene therapy manufacturing operations, including Veeva QMS, BMRAM, analytical lab instruments, and the Metasys Client.
• Maintain data integrity and system compliance to ensure 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.

Education & Experience

• 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.