Validation Engineer II/III

Genezen•Lexington, KY

4d•Onsite

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. Genezen is hiring a Validation Engineer II/III to support validation and manufacturing operations by executing and documenting equipment, utility, facility, and process qualification activities. The role will assist in process transfers, scale-up, and process validation efforts while ensuring compliance with internal procedures, cGMPs and regulatory requirements. Responsibilities include preparing validation protocols and reports, supporting the manufacture of cGMP materials, conducting risk assessments, and developing and maintaining quality system documentation, including SOPs, technical reports, and validation records. The position works cross-functionally to ensure projects are completed on schedule and in accordance with quality and regulatory expectations.

Requirements

Bachelor's degree in Engineering, Biotechnology, Biological Sciences, or a related technical discipline.
5-8 years of validation experience
Experience working in clean room environments.
Experience with aseptic fill finish technique.
Experience with validation lifecycle management and continued process verification.
Strong interpersonal and communication skills, both verbal and written, with demonstrated experience preparing technical documents such as protocols, reports, SOPs, and risk assessments.
Ability to work collaboratively as part of cross-functional teams maintaining effective communication with project team members to achieve project objectives including effectively reporting project activity in a clear and concise manner.
Proficiency in Microsoft Office applications, including Excel, Word, PowerPoint, and Visio, with the ability to develop technical documentation, analyze data, and create process flow diagrams.
Demonstrated ability to effectively manage competing priorities, adapt to changing business needs, and meet challenging deadlines in a fast-paced environment while maintaining quality, compliance, and adherence to project timelines.
Strong working knowledge of GxP regulations including 21 CFR Parts 11, 210/211, EU GMP Annex 1 and 11, data integrity guidances, ICH guidelines with the ability to assess compliance risks.

Responsibilities

Protocol generation, execution support, data analysis, report generation and approval for various installation, operational and performance qualification activities
Review and approve qualification documentation on behalf of the validation department.
Ensure performance of all qualification activities is in accordance with internal procedures, industry best practices and regulatory guidance.
Support investigations in protocol nonconformances, deviations discrepancies, and failures.
Support root-cause investigations and development of appropriate CAPAs.
Serve as initiator and owner of validation related change controls and corrective and preventative actions.
Author standard operating procedures related to validation practices.
Review engineering and technical documentation, including P&IDs, equipment specifications, drawings, manuals, and functional/design specifications.
Support commissioning and startup activities and ensure appropriate transition from commissioning to qualification
Support the execution and generation of formal risk assessments.
Support the generation and implementation of validation programs.
Identify opportunities to improve validation processes, reduce execution timelines, and increase operational efficiency while maintaining compliance.
Support audits and regulatory inspections, as needed.