Job Description

Umoja Biopharma is a game-changing biotech start-up with locations in Seattle, WA and Boulder, CO, focused on transforming the treatment of cancer with a novel integrated immunotherapy platform. Our vision is to develop off-the-shelf therapies capable of treating any tumor, any time. We are a diverse and growing team working in brand-new facilities in downtown Seattle, Washington, and Boulder, Colorado, and we are looking for innovative thinkers who are excited by groundbreaking science and technology, and passionate about squaring up to the challenges inherent to cutting edge drug development. We are committed to the principles of Diversity Equity and Inclusion and strongly invite applications from enthusiastic individuals who share our commitment and help position Umoja as a leader in this front.

We at Umoja believe in the importance of stories; we are looking for great people to join our team to help us create more stories for ourselves, for you, and most importantly for patients and their families. 

Umoja Biopharma – Your Body. Your Hope. Your Cure. 

Position Summary

Umoja Biopharma is seeking a Senior Facilities Engineer to support the start-up of our state-of-the-art lentiviral vector development and manufacturing facility in Louisville, Colorado. Primary responsibilities for this position include the development and ownership of site services, plant utilities, and building systems to ensure reliable performance and effective hand-off of the facility from construction to operation.

Specifically, this individual will serve as the Subject Matter Expert (SME) and provide technical oversight during the start-up, commissioning, qualification, operation, and maintenance of plant utility systems such as HVAC systems, heating hot water systems, chilled glycol water systems, plant steam, compressed gas systems and the RODI water system.

Additionally, this individual will play a pivotal role in the development and delivery of facilities programs, building software and GMP support systems including site security programs, pest control, janitorial services, the Building Management System (BMS), and the Environmental Monitoring System (EMS).

Core Accountabilities

Specific responsibilities include:

• Facilitate start-up operations and provide technical oversight for receipt, installation, commissioning, and qualification of utility and building infrastructure systems.
• Serve as the Subject Matter Expert (SME) for plant utilities, building systems, facility maintenance and facility service programs.
• Draft and review standard operating procedures enabling operational readiness and site services including pest control, site security, janitorial services, and facility maintenance.
• Develop and own technical documentation including operation and maintenance procedures for plant utilities, GMP support systems, and building systems.
• Oversee existing facilities operations with a broad range of responsibilities related to facility and site management (e.g., vendor coordination, documentation management, and coordination with other functional areas).
• Provide leadership, direction, and staff oversight for Facilities and Maintenance technicians.
• Develop maintenance and calibration service events in Umoja’s CMMS including the development of an up-to-date working spare parts inventory system for utilities and building systems.
• Apply GEP (Good Engineering Practice) to support maintenance functions in the identification, troubleshooting, and repair of complex facility, equipment, or system failures.
• Interpret and review utility, process system/equipment, plumbing, ductwork plans, architectural, and P&IDs.
• Partner with Umoja Validation to facilitate the planning and coordination of commissioning and validation protocol execution.
• Provide technical engineering support to develop scope of work, project execution plans, and associated requirements for equipment installation, modification, replacement, and decommissioning in accordance with site specifications.
  

• Bachelor’s degree in mechanical, chemical, or electrical engineering with a minimum of 5-7 years of facilities or plant engineering experience OR a Bachelor’s degree in another engineering discipline and a minimum of 3 years of experience in facilities management, project engineering, or facilities construction.
• Knowledge of facilities operations typical to a cGMP manufacturing environment.
• Independent and risk-based decision-making capability.
• Ability to work effectively and efficiently in a collaborative manner across multiple functional areas.
  

• Proficient in the operation of building automation systems including BMS, EMS, and standalone PLCs required for proper building, equipment, and system operation.
• Experience or familiarity applying various project management tools for schedule, budget, and resource management and reporting.
• Previous experience supporting a cGMP biopharmaceutical manufacturing facility startup and/or operations environment.
• Experience in cGMP cell and gene therapy manufacturing and/or testing facility.
  

• Ability to wear personal protective equipment (PPE) including gloves, protective clothing, and eye safety glasses.
• Ability to perform physical tasks including standing, use of hands, walking, bending, kneeling, and occasionally moving materials up to 30 pounds.