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).
5 7+ 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.
Numbers & Facts
Location
Cincinnati, OH
Skills
Analysis Skillsunmatched
Biologyunmatched
Biotech and Pharmaceuticalunmatched
Change Controlunmatched
Change Managementunmatched
Code of Federal Regulationsunmatched
Computer Scienceunmatched
Computer Skillsunmatched
Computer Systemsunmatched
Data Qualityunmatched
ERP (Enterprise Resource Planning)unmatched
Functional Testingunmatched
Gene Therapyunmatched
GxPunmatched
High Performance Liquid Chromatography (HPLC)unmatched
Instrumentationunmatched
Laboratoryunmatched
Laboratory Information Management System (LIMS)unmatched
Laboratory Operationsunmatched
Maintain Complianceunmatched
Manufacturing Operationsunmatched
Medical Equipmentunmatched
NetSuiteunmatched
Patient Safetyunmatched
Polymerase Chain Reaction (PCR)unmatched
Process Validationunmatched
Property Managementunmatched
Quality Assuranceunmatched
Regulationsunmatched
Regulatory Complianceunmatched
Requirements Validation/Verificationunmatched
Risk Analysisunmatched
Software Patchesunmatched
System Validationunmatched
Systems Administration/Managementunmatched
Technical Writingunmatched
Validation Planunmatched
Writing Skillsunmatched
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