More jobs:
CSV Engineer
Job in
Columbus, Franklin County, Ohio, 43224, USA
Listed on 2026-06-03
Listing for:
Katalyst CRO
Full Time
position Listed on 2026-06-03
Job specializations:
-
Quality Assurance - QA/QC
Data Analyst
Job Description & How to Apply Below
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.
- 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 (Net Suite).
- 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.
- 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.
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