Process Engineer, III/Senior

Genezen•Lexington, MA

5d•$105,000 - $140,000

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 plays a key role supporting operations at 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 medium to large projects. This position will be filled at the Engineer III or Sr. Engineer level, dependent upon the qualifications and experience of the successful candidate. Provides technical support to development and manufacturing groups, utilizing data analysis and evaluation of multiple variables. Develops solutions to complex problems using ingenuity and innovation, and ensures solutions are consistent with overall organization objectives. Drives key equipment, control system, and facility improvement projects, providing oversight of design, construction, testing, and turnover with responsibility for schedule, budget, and overall project performance. Provides technical input for product tech transfers, evaluation of process requirements versus facility capabilities. Provides technical support and analysis for the resolution of deviations, investigations, and process issues. Works independently to develop department procedures, standards, and specifications Other duties as assigned.

Requirements

B.S. in Chemical or Mechanical Engineering
5+ Years of relevant working experience in comparable position (similar type of work, similar group dynamics)
Excellent interpersonal, teamwork, and leadership skills
Must be capable of multi-tasking and performing assignments that have loosely defined objectives which require investigation of numerous variables.
Ability to apply knowledge of multiple engineering disciplines to evaluate and develop solutions for operational issues.
Must be able to plan, coordinate, perform, and document work with minimal supervision.
Proficiency with Microsoft products and ability to learn additional applications as needed.
Must be able to work on complex problems in which analysis of situations or data requires and in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
Experience with pharmaceutical / biopharmaceutical equipment commissioning, validation, and performance monitoring
Proven experience and proficiency troubleshooting process and process support system issues.
Must be familiar with process control system programming and operation.
Incumbent will be required to carry a cellular phone and be on call to support manufacturing operations.
A valid driver’s license is required for travel to vendor and / or consultant offices.
Travel to accommodate vendor visits, domestic and international may be required.

Responsibilities

Provides technical support to development and manufacturing groups, utilizing data analysis and evaluation of multiple variables.
Develops solutions to complex problems using ingenuity and innovation, and ensures solutions are consistent with overall organization objectives.
Drives key equipment, control system, and facility improvement projects, providing oversight of design, construction, testing, and turnover with responsibility for schedule, budget, and overall project performance.
Provides technical input for product tech transfers, evaluation of process requirements versus facility capabilities.
Provides technical support and analysis for the resolution of deviations, investigations, and process issues.
Works independently to develop department procedures, standards, and specifications
Other duties as assigned.