POSITION SUMMARY
Umoja Biopharma is seeking a Process Engineer II to support on-going cGMP manufacturing and process development 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 ACCOUNTABILITIES
Specific responsibilities include:

• Serve as SME and system owner for processing equipment (e.g. single-use bioreactors, chromatography systems, TFF systems, Flex 2, ViCell, etc)
• Ensure equipment is active, maintained properly and compliant.
• Provide day-to-day engineering support for process equipment and plant operations.
• Manage equipment failure, investigations, troubleshooting efforts, and corrective actions.
• Maintain spare parts program for production equipment.
• Collaborate with key stakeholders on change control management, work orders, and CAPA execution for new and existing equipment.
• Perform engineering assessments for new equipment implementation, process equipment changes, etc.
• Execute design, preparation of cost, scheduling and any potential facility modifications required. Coordinate installation, qualification, and commissioning, and turnover 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.
• Serve as owner of deviation records and 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 standard operating procedures and user requirement specifications for equipment.

The successful candidate will have:

• Bachelor’s degree in engineering (chemical or mechanical, preferred) and 5 years of operations-related experience in a cGMP manufacturing environment.
• 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. Net Suite-Coupa)
• Experience with Sartorius bioreactor systems and BioBrain, UNICORN, 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 regularly.

Salary Range: $107,100 - $132,300