Sr. Process/Validation 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.

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.

• •Prepare, schedule, coordinate and monitor their assigned engineering projects
• •Manage projects associated with workflow optimization, mistake-proofing, and continuous improvement.
• •Supports 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

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

• •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

• •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

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

• •Frequently utilize close vision and the ability to adjust focus

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

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.

• •Paid vacation days, amount based on tenure
• •Paid sick time
• •10 observed holidays + 2 flo