Senior CSV Validation Engineer

Genezen•Lexington, KY

About The Position

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

Requirements

A minimum of a bachelor’s degree in Engineering, Computer Science or related discipline
7+ years of Computer System Validation experience
Strong understanding of GxP computerized systems and validation principles with experience leading validation projects for Enterprise, Laboratory, Manufacturing, and Quality Systems.
Demonstrated experience developing and executing risk-based CSV strategies
Experience with computerized system periodic reviews
Experience with audit trail and data integrity assessments
The ability to communicate effectively 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
The ability to communicate and work effectively with fellow project team members
Ability to work well with diverse groups in a matrix-style, growing, safety focused organization
Understanding of cGMP regulations
Strong technical writing skills
Strong working knowledge in Microsoft Office (Word, Excel, Visio, etc.) and Adobe Acrobat
Strong project management skills with the ability to manage multiple activities with challenging timelines
Strong working knowledge of 21 CFR Part 11, EU GMP Annex 11, ICH guidelines, GAMP 5 and data integrity guidelines

Responsibilities

Lead risk-based validation strategies for GxP computerized systems throughout the system lifecycle including protocol generation, oversee execution, data analysis, report generation and approval of qualification activities for GxP 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, EU, ISO, Data Integrity guidances, and internal procedures and standards
Assess the impact of system-related events on the system’s validated state and data reliability.
Lead validation execution and ensure testing is appropriately documented
Support quality events involving CSV in protocol nonconformances, deviations, investigations, CAPAs, and change controls.
Serve as initiator and owner of validation related change controls and corrective and preventative actions
Develop, author and improve CSV procedures, templates, standards, and guidance.
Monitor industry and regulatory trends and recommend improvements to company practices
Support the execution and generation of formal risk assessments
Support and conduct periodic reviews
Support the evaluation of data lifecycles and data flow from creation through processing, review, approval, reporting, retention, and archival
Support risk-based Data Integrity Assessments and the audit trail review process
Identify data integrity risks and partner with system owners to implement remediation plans
Provide CSV and Data Integrity expertise during vendor selection and qualification.
Define expectations for vendor testing, validation documentation, audit trails, electronic signatures, and data retention.
Provide guidance to project teams, system owners, IT, and vendors regarding GxP validation requirements
Promote a strong data integrity culture across GxP functions
Support audits and regulatory inspections in representing CSV, as needed