CSV Engineer

Katalyst CRO; Seattle (WA); On-site; USD 110,000 - 160,000; Full time

Job summary

Katalyst CRO is seeking a CSV Engineer to validate GxP computerized systems at client sites in the United States. The role leads validation activities for systems such as Veeva QMS, BMRAM, and analytical instruments, ensuring data integrity, quality, and inspection readiness.

Responsibilities include authoring validation plans and protocols, performing risk assessments, and managing change controls and CAPAs within Forge's quality system.

Qualifications

• 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.

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.

Skills

GxP validation

Regulatory compliance

Technical writing

Risk assessment

Audit trail review

Change control

Validation protocol execution

Education

Bachelor's degree in Computer Science or related field

Tools

Veeva Vault QMS

BMRAM

Analytical lab instruments (HPLC/UHPLC/PCR)

NetSuite ERP

Metasys Client

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.
• 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.

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.