Process Engineer I

Genezen•Lexington, MA

1d•$65,000 - $85,000

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. The Process Engineer I plays a key role in supporting Genezen’s gene therapy clinical/commercial manufacturing facility and will provide operational support to all development, clinical, and commercial operations groups including MFG, FAC, QC, SC, and PD. The incumbent will provide a variety of support services including equipment performance evaluation, troubleshooting, procedure development, process and equipment monitoring, validation / qualification, and leadership of small projects.

Requirements

BS in Chemical or Mechanical Engineering
0-3 years of relevant working experience in a comparable position (similar type of work, similar group dynamics)
Must be able to communicate effectively in writing and orally across the organization and at multiple levels.
Positive attitude, service oriented, and willingness / ability to perform maintenance on all equipment, systems, and facilities.
Must be capable of multi-tasking and performing assignments that have loosely defined objectives which require investigation of numerous variables.
Incumbent will be required to carry a cellular phone and be on call to support manufacturing operations.
Experience with pharmaceutical / biopharmaceutical equipment commissioning, validation, and performance monitoring.

Nice To Haves

Experience in cell culture, protein purification, or process control systems is desirable.

Responsibilities

Provides operational support to development, clinical, and commercial operations groups including MFG, FAC, QC, SC, and PD
Supports specification, design, testing, and implementation of single use manufacturing systems.
Works on problems of where analysis of data requires evaluation of numerous factors. Demonstrates good judgement in selecting methods and techniques for obtaining solutions.
Supports projects to modify/improve equipment, facilities and/or process controls.
Provides technical support and analysis for the resolution of deviations, investigations, and process issues.
Supports improvements to department procedures and specifications.
Other duties as assigned