Process/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. 

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 Sr. Process/Validation Engineer plays a key role supporting operations at Genezen’s gene therapy facility and will provide operational support to all groups including MFG, FAC, QC, SC, MSAT and PD. The incumbent will provide a variety of support services including equipment performance evaluation, troubleshooting, procedure development, process and equipment monitoring, validation / qualification, CI’s and leadership of medium to large projects.   

ESSENTIAL JOB FUNCTIONS

•  Prepare, schedule, coordinate and monitor their assigned engineering projects 

• Manage projects associated with workflow optimization, mistake-proofing, and continuous improvement. 

• Supports change management processes to achieve desired business outcomes in a complex business environment. 

• Monitor compliance to all applicable FDA and EU practices, QA/QC policies, performance standards and specifications. 

• Interact daily with internal team members and external third parties to interpret their needs and requirements and represent them in the field. 

• Perform overall quality control of their work (budget, schedule, plans, personnel performance) and report regularly on project and maintenance/calibration status. 

• Cooperate and communicate effectively with team members, other project participants, and upper management to assist with technical support. 

• Be seen as technical engineering expert and be responsible for daily operations team huddle and daily site standup meeting providing updates on equipment, qualification status, documentation, and any CAPA’s or deviations.  

• Troubleshoot equipment and systems issues and develop solutions. 

• Ensure internal and external team members/contractors maintain the highest quality standards.