Validation Engineer II/III

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

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.

JOB 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.

SPECIAL WORK REQUIREMENTS

• Fully onsite position
• Adaptability required as work schedule may change based on business needs
• Criminal background check required
• Other duties as assigned

EDUCATION/CERTIFCATIONS/LICENSES

Bachelor's degree in Engineering, Biotechnology, Biological Sciences, or a related technical discipline.

Essential

ON-THE-JOB EXPERIENCE

5-8 years of validation experience

Essential

Experience working in clean room environments.

Essential

Experience with aseptic fill finish technique.

Essential

Experience with validation lifecycle management and continued process verification.

Essential

KNOWLEDGE, SKILLS AND EXPERIENCE

Strong interpersonal and communication skills, both verbal and written, with demonstrated experience preparing technical documents such as protocols, reports, SOPs, and risk assessments.

Essential

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.

Essential

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.