Manager/Sr. Manager, Process Engineering

Genezen•Lexington, MA

13d•$130,000 - $170,000•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. 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.

Requirements

B.S. in Chemical, Biomolecular, or Biomedical Engineering
8+ years of relevant working experience including 3 years of management experience in a comparable position (similar type of work, similar group dynamics)
In-depth operational knowledge of single-use process equipment such as bioreactors, chromatography skids, UF/DF and mixing systems.
Experience troubleshooting support utilities such as WFI, Pure Steam generators and compressed gas systems.
Excellent communication, 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.
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.
Experience with pharmaceutical / biopharmaceutical equipment commissioning, validation, and performance monitoring
Proven experience and proficiency troubleshooting process and process support system issues.

Nice To Haves

Experience with fill-finish equipment is highly desirable.

Responsibilities

Represent department at client and cross functional meetings serving as the key stakeholder for all process engineering related topics.
Drives necessary equipment, control system, and facility improvement projects, providing oversight of design, construction, testing, and turnover with responsibility for schedule, budget, and overall project performance.
Provide technical input for product tech transfers, evaluation of process requirements versus facility capabilities.
Provide technical support and analysis for the resolution of deviations, investigations, and process issues.
Works independently to develop department procedures, standards, and specifications.
Manage and mentor engineering staff providing clear direction, expectations and goal setting.
Maintain team metrics related to on-time delivery and provide routine status updates to management.
Perform goal setting and period performance reviews of direct reports in alignment with corporate objectives.
Adaptability required as work schedule may change based on business needs
Criminal background check required
Other duties as assigned