Sr. CSV Validation Engineer

The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures.

Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast‑growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work.

Every employee contributes to the success of the company and you can be part of that team.

The incumbent is responsible for leading computerized systems validation projects. This includes qualification of GxP computerized systems for both laboratory and manufacturing based equipment as well as GMP software applications. Key deliverables are preparation of relevant documentation to meet regulatory requirements for new and existing products (Validation Plans, User Requirements Specifications (URS), Risk Assessments, IQ/OQ/PQ protocols and Traceability Matrices). Collaborate with cross functional teams, ensure compliance with regulatory requirements, and drive best‑in‑class validation practices that support our Quality Management System and operational excellence.

• Lead Protocol generation, oversee execution, data analysis, report generation and approval of qualification activities for GMP software applications
• Review and approve qualification documentation on behalf of the validation function
• Evaluate, audit, and guide software validation activities to ensure compliance with FDA, ISO, Data Integrity guidance, and internal standards
• Support investigations into protocol nonconformances and site deviations
• Serve as initiator and owner of validation related change controls and corrective and preventative actions
• Author standard operating procedures related to CSV validation practices
• Support the execution and generation of formal risk assessments
• Enhance CSV validation programs
• Analyze validation data, identify gaps, and support investigations and corrective actions
• Represent CSV during audits and regulatory inspections

• Fully onsite position
• Strong communication skills
• Familiarity with Microsoft Office, Excel, and Visio
• Ability to work well with diverse groups in a matrix‑style, growing, safety focused organization
• Ability to manage multiple activities
• The ability to communicate with fellow project team members
• Criminal background check required
• Other duties as assigned

A minimum of a Bachelor’s degree in Engineering, Computer Science or related discipline

7+ years of Computer System Validation experience

• In depth CSV experiences including as a Validation lead
• The ability to communicate with employees of all experience levels from Genezen and other contract firms
• The ability to report on project activity in a clear and concise manner
• Understanding of cGMP regulations
• Technical writing ability
• Familiarity with Microsoft Office
• Ability to work well with diverse groups in a matrix‑style, growing, safety focused organization
• Ability to manage multiple activities with challenging timelines
• In depth knowledge of 21 CFR Part 11, EU GMP Annex 11 and GAMP5 computerized system

The annual salary range for this position based upon level hired is: $115,000 - $140,000

• Regularly sit for extended periods of time

• Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms
• Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

• Frequently lift and/or move up to 10 pounds
• Rarely lift and/or move up to 25 pounds

• Frequently utilize close vision and the ability to adjust focus

• Frequently required to communicate by talking, hearing, using telephone and e‑mail