Process 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

Responsible mid-level engineer to support site engineering and technical disciplines that support gene therapy processes which encompass facilities, maintenance, capital projects, validation, EHS and continuous improvement. The right individual for this position must be able to work independently and as a group contributor. This individual must be able to change directions in a fast-paced environment. This person will be responsible for project management, CQV, master planning. CAPEX / OPEX, change control, and continuous improvements / optimization and ensuring all project and day-to-day activities are performed and compliant to all site EHS policies and procedures while maintaining accuracy and quality from conception to completion. This individual will be a key player in driving improvements and developing improved system and process operational design and procedures through site efficiency initiatives.

ESSENTIAL JOB FUNCTIONS

• Prepare, schedule, coordinate and monitor their assigned engineering projects
• Manage projects associated with workflow optimization, mistake-proofing, and continuous improvement.
• Support 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.
• Execute, development / implementation / maintenance of environmental and safety management systems.
• Coordinates the day-to-day implementation of the site safety and environmental policies and procedures.
• Develops and conducts periodic safety audits / assessments to evaluate compliance to facility safety & environmental policies & procedures.
• Troubleshoots equipment and systems issues and develops solutions.
• Ensure internal and external team members / contractors maintain the highest quality standards.
• Identifying deficiencies in MEP processes and developing improvements.
• Developing, initiating, and managing all phases of projects, maintenance / calibration, and EHS.
• Preparing documentation of critical analysis and providing suggestions for correcting errors across projects, maintenance / calibration, and EHS

KNOWLEDGE, SKILLS AND EXPERIENCE

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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 museumto 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.