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, and EHS. 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.

ESSENTIAL JOB FUNCTIONS

  • Prepare, schedule, coordinate and monitor their assigned engineering projects
  • Monitor compliance to all applicable FDA and EU practices, QA/QC policies, performance standards and specifications
  • Interact daily with internal team member 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

SPECIAL WORK REQUIREMENTS

  • Adaptability required as work schedule may change based on business needs
  • Criminal background check required
  • Other duties as assigned

KNOWLEDGE, SKILLS AND EXPERIENCE

EDUCATION/CERTIFCATIONS/LICENSES

BS/BA degree in Engineering, Science, Technical or related field

Essential

PMP certification

Pharmaceutical, Biomedical, or Medical Device experience

Desired

Desired

ON-THE-JOB EXPERIENCE

Proven working experience as an Engineer, Project Manager with experience in CQV, master planning. CAPEX/OPEX, change control, and continuous improvements/optimization

Essential

Adherence to all local, state, and governmental safety standards

Essential

Excellent knowledge of design and visualization software such as AutoCAD

Essential

Familiarity with rules, regulations, best practices, and performance standards

Essential

SKILLS/ABILITIES

Advanced MS Office skills

Essential

Project management and supervision skills

Essential

Decision making ability and leadership skills

Essential

Time management and organization skills

Essential

Ability to work with multiple discipline projects

Essential

Work Environment

  • Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning
  • Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities
  • Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock
  • Occasionally exposed to extremely loud noise levels
  • Spending time on the floor during activity execution (maintenance, construction, commissioning, and qualification) is required

Movement

  • Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms 
  • Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting

  • Frequently lift and/or move up to 10 pounds
  • Occasionally lift and/or move up to 25 pounds

Vision

  • Frequently utilize close vision and the ability to adjust focus

Communication

  • Frequently required to communicate by talking, hearing, using telephone and e-mail

 

 

GENEZEN'S VALUE-BASED COMPETENCIES

Growth Mindset
Believe that skill is developed through dedication and hard work.
Intelligence & talent are just the starting point.
Mistakes are valuable lessons, not shameful indictments.

Flexibility
Adapt rapidly to a quickly changing, CDMO environment.
Respond by constructively creating & impacting opportunity through active participation.

Team Focus
Work together; succeed together; fail together.

Integrity
Do the right thing, on time, every time.
Speak up when needed.
Exercise respect.

Inclusion
Embrace the unique viewpoint of each individual.
Join the ongoing journey to a more inclusive workplace and community where we all help each other get better.

GENEZEN'S BENEFITS

  • Paid vacation days, amount based on tenure, and paid sick time
  • 8 observed holidays + 1 floating holiday + 1 volunteer day
  • 401(k) plan with company match up to 6% of salary, vested immediately
  • Choice of six healthcare plans
  • FSA and HSA programs
  • Dental & vision care
  • Employer-paid basic term life/personal accident insurance
  • Voluntary disability, universal life/personal accident 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 is located in Fishers, Indiana.
  • This position requires a criminal background check.
  • Genezen is an Equal Opportunity Employer.
  • 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 is located in Fishers, Indiana, 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.

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