Facilities & Engineering Document Control Specialist; Temp

Overview

The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, GMP viral vectors, and 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 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 The FAC/ENG Document Control Specialist temp role is responsible for managing the Blue Mountain Regulatory System, which includes the oversight and approval of assets, systems, and equipment. The role also involves assigning system numbers and working with the facilities manager and engineering to create maintenance assessments of work plans and obtain appropriate signatures. The specialist will oversee the Document Control and Archival Process for GMP Facilities and Engineering documents, ensuring compliance with regulatory, quality, and company requirements.

• Work with the Facilities Manager and Engineering to create maintenance events and work plans and oversee all corresponding department approvals.
• Coordinate maintenance activities.
• Assign maintenance activities.
• Schedule maintenance activities.
• Close all final maintenance work related tasks.
• Update monthly reports related to Maintenance Work Orders and General Work Orders.
• Oversee Archive Room operations.
• Manage and oversee the Document Control and Archival Process of GMP Facilities and Engineering documents.
• Maintain an effective document tracking process.
• Provide FAC/ENG backroom support during regulatory and/or third-party inspections.
• Other duties as they arise.

• Criminal background check required.
• Other duties as assigned.

• High school diploma or Equivalent
• Minimum of 3 years in a GMP environment

• Mechanical aptitude required
• Positive attitude, service oriented, and willingness / ability to perform tasks deemed essential
• Attention to detail and an ability to see jobs through to completion
• Relevant trade skills such as plumbing, electrical, HVAC a plus
• Proven experience operating and maintaining building support functions is a plus

This is a temp position that will be hired through a 3rd party agency. The hourly rate for the position is $30-$35/hr

Outlined here are typical physical demands and work environment expectations associated with the role.

• Regularly sit for long periods of time
• Movement: frequently stand; sit; walk; balance; stoop; kneel; crouch; use hands to finger, handle, or feel; reach with hands and arms. Occasionally walk; climb or balance; stoop, kneel, crouch, or crawl.
• Lifting: frequently lift and/or move up to 10 pounds; rarely 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.

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.

• Paid vacation days, amount based on tenure
• Paid sick time
• 10 observed holidays + 2 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
• AD&D Insurance

• 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 operates two locations:
Fishers, Indiana and Lexington, Massachusetts. Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money…