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
- BS/BA degree in Engineering, Science, Technical or related field
- Pharmaceutical, Biomedical, or Medical Device experience
- 3+ years of engineering/project management experience
- Proven working experience as an Engineer, Project Manager with experience in CQV, master planning. CAPEX/OPEX, change control, and continuous improvements/optimization
- Adherence to all local, state, and governmental safety standards
- Excellent knowledge of design and visualization software such as AutoCAD
- Familiarity with rules, regulations, best practices, and performance standards
- Advanced MS Office skills
- Decision making ability and leadership skills
- Time management and organization skills
- Ability to work with multiple discipline projects
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.
- Ability to work in a BSL 2 with personal protective equipment.
- While performing the duties of this job, the employee is frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. The employee is occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.
- In the performance of the duties of this job the employee is required to communicate using telephone and e-mail.
- While performing the duties of this job, the employee must be aware of potential exposure to moving mechanical parts; high, precarious places; toxic or caustic chemicals; high noise areas, and risk of electrical shock.
- A physically able individual is required who can spend time on the floor during activity execution (maintenance, construction, commissioning and qualification).
GENEZEN'S CURES VALUE-BASED COMPETENCIES
Committed to Science
We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.
Urgency in action for the patients
We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.
Resilience & Grit in operations
We are committed to overcoming challenges, learning from failures, and persistently striving for success.
Execute with Excellence & Integrity
We are dedicated to delivering quality results and upholding ethical principals.
Solutions driven for our partners
We are committed to being a proactive, collaborative, creative and open-minded partner.
GENEZEN'S BENEFITS
- Paid vacation days, amount based on tenure
- Paid sick time
- 9 observed holidays + 1 floating holiday + 1 volunteer day
- 401(k) plan with company match up to 6% of salary, vested immediately
- Share Appreciation Rights
- Choice of several healthcare plans
- FSA and HSA programs
- Dental & vision care
- Employer-paid basic term life/personal accident insurance
- Voluntary disability, universal life/personal accident insurance
- Accidental Death & Dismemberment (AD&D) Insurance
ADDITIONAL DETAILS
- Nothing in the job description for this role restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
- This position requires a criminal background check.
- Genezen is an Equal Opportunity Employer.
- Genezen participates in EVerify.
- Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.
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.
Top Skills
What We Do
Founded in Indianapolis in 2014, Genezen is focused on supporting the demands of the current and future gene and cell therapy manufacturing market worldwide— making viral vector production accessible to both early-stage, growth-oriented companies and established industry leaders. Genezen offers early-phase process development, GMP lentiviral vector production, retroviral vector production, and analytical testing services, building on the company's expansive knowledge and experience in the industry and working with the nation's leading institutions. For more information, or to learn more about services offered in Genezen's new cGMP facility, please visit our website: www.genezen.com
