Sr. CSV Validation Engineer

Responsibilities

• Lead protocol generation, execution, data analysis, and report generation for GMP software applications
• Review and approve qualification documentation for the validation function
• Evaluate and guide software validation activities to ensure compliance with FDA, ISO, and Data Integrity guidance
• Support investigations into protocol nonconformances and site deviations
• Serve as owner of validation-related change controls and CAPAs
• Author standard operating procedures related to CSV validation practices
• Support the execution and generation of formal risk assessments
• Represent CSV during audits and regulatory inspections

Requirements

• Bachelor’s degree in Engineering, Computer Science, or a related discipline
• 7+ years of Computer System Validation experience
• In-depth experience as a Validation Lead
• Understanding of cGMP regulations
• In-depth knowledge of 21 CFR Part 11, EU GMP Annex 11, and GAMP5
• Strong technical writing ability
• Proficiency with Microsoft Office, Excel, and Visio

About the Company

Genezen provides process development, produces GMP viral vectors, and provides cell transduction for gene and cell therapy clinical trials to support new cures.