Process Engineer, III / Senior

Job Description

Job Description

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.

KNOWLEDGE, SKILLS & EXPERIENCE

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.

PAY RANGE :

This position will be filled at the Engineer III or Sr. Engineer level, dependent upon the qualifications and experience of the successful candidate. The annual salary range for the Scientist I-III is $105,000-$140,000.

PHYSICAL DEMANDS

While performing the duties of this job, the employee is required to meet the following physical demands :

Work Environment

Movement

Lifting

Vision

Communication

GENEZEN'S CURES VALUE-BASED COMPETENCIES

C ommitted to Science

We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.

U rgency in action for the patients

We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.

R esilience & Grit in operations

We are committed to overcoming challenges, learning from failures, and persistently striving for success.

E xecute with Excellence & Integrity

We are dedicated to delivering quality results and upholding ethical principals.

S olutions driven for our partners

We are committed to being a proactive, collaborative, creative and open-minded partner.

GENEZEN'S BENEFITS

ADDITIONAL DETAILS

Genezen has operates two locations : one in Fishers, Indiana and the second in Lexington, Massachusetts.

Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world's largest children's museum to name just a few reasons why this area is a great place to live.

Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.