Process Engineer II

Umoja Biopharma is a game-changing biotech start-up with locations in Seattle, WA and Louisville, 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 Louisville, 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 Process Engineer II to support on-going cGMP manufacturing operations at Umoja's Colorado Laboratory & Innovative Manufacturing Building (The CLIMB) in Louisville, CO. The primary responsibility of this position will be to serve as the system owner and subject matter expert for production equipment.

This individual must demonstrate clear communication, effective collaboration skills and a proven ability to operate independently.

CORE ACCOUNTABILITIESSpecific responsibilities include:

• Serve as SME and system owner for manufacturing production equipment.
• Ensure equipment is active, compliant and maintained properly.
• Provide day-to-day engineering support for the process equipment and plant operations.
• Support equipment failure, troubleshooting, and repairs.
• Collaborate with key stakeholders on change control management, work orders, and CAPA execution for new and existing equipment.
• Provide engineering support when purchasing new processing equipment.
• Assist with design, preparation of cost, scheduling and any potential facility modifications required.
• Coordinate installation, qualification, and commissioning, and turn over for production as well as training and knowledge transfer to Supervisors, Operators and Maintenance personnel.
• File pertinent documentation including specifications, drawings, O&M manuals, and service records in our CMMS system and document management systems.
• Ensure proper investigation and prompt closure of equipment-related deviations.
• Coordinate and assist with execution of validation processes including protocols, summary reports, IQ/OQ/PQ and FAT/SAT qualifications for process equipment.
• Maintain training on SOPs, O&M manuals and P&IDs.
• Authoring and reviewing of standard operating procedures and user requirement specifications for manufacturing equipment.

The successful candidate will have:

• Bachelor's degree in engineering or sciences (chemical or mechanical, preferred) and a minimum of 2 years of operations-related experience in a cGMP manufacturing environment. Equivalent combinations of advanced education and experience will be considered.
• Work independently with risk-based decision-making capability.
• Commitment to following safety protocols and work practices.
• Ability to work efficiently, effectively, and collaboratively in a matrix environment.

Preferred Qualifications:

• Experience executing commissioning and validation protocols.
• Experience with asset management and work order systems (e.g. BMRAM.)
• Experience with ERP systems (e.g. SAP.)
• Experience with UNICORN and Biobrain, and proficient with standalone PLC and HMI navigation.

Physical Requirements:

• Ability to wear personal protective equipment 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.
• Ability to work off hours, on-call, and/or weekends on occasion or in emergency situations.
• Ability to work onsite with some flexibility to work from home when applicable.

Salary Range: $93,500 - $113,500

Benefits Offerings

Umoja Biopharma offers its employees competitive Medical, Dental, and Vision plans. Additionally, we offer Umojians access to a 401k plan through Fidelity, with a 100% match up to their first 6% deferral. Umoja also provides a generous Paid Time Off policy, employee commuter benefits, and cell phone stipend. For a full breakdown of our benefits offerings, please see the Benefits section of our website.