Process Engineer II, Equipment

ZipRecruiter; Louisville (KY); On-site; USD 94,000 - 117,000; Full time

Job summary

Join a pioneering biotech firm dedicated to transforming cancer treatment through innovative immunotherapy. As a Process Engineer II, you will play a crucial role in supporting cGMP manufacturing and process development. Your expertise will guide the maintenance and compliance of production equipment, ensuring the highest standards are met. Collaborate with a diverse team of professionals in a dynamic environment that values groundbreaking science and technology. This is an exciting opportunity to contribute to meaningful advancements in healthcare while working in state-of-the-art facilities.

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

401(k) with 100% match

Generous PTO

Commuter Benefits

Cell Phone Stipend

Qualifications

• 5+ years in cGMP manufacturing operations.
• Bachelor's degree in engineering required.
• Ability to work independently and collaboratively.

Responsibilities

• Serve as SME for processing equipment and ensure compliance.
• Manage equipment failure investigations and corrective actions.
• Document specifications and maintain training on SOPs.

Skills

cGMP Manufacturing

Risk-Based Decision Making

Safety Protocols

Effective Collaboration

Education

Bachelor's in Chemical Engineering

Bachelor's in Mechanical Engineering

Tools

BMRAM

NetSuite

Coupa

Sartorius Bioreactor Systems

BioBrain

UNICORN

Job description

Job Description

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 addressing the challenges of cutting-edge drug development.

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 Process Engineer II to support ongoing cGMP manufacturing and process development operations at our 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 the ability to operate independently.

Core Accountabilities

• 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, properly maintained, 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 and process equipment changes.
• Execute design, prepare costs, schedules, and coordinate installation, qualification, commissioning, and turnover for production, including training and knowledge transfer to Supervisors, Operators, and Maintenance personnel.
• Document specifications, drawings, O&M manuals, and service records in our CMMS and document management systems.
• Manage deviation records, ensuring proper investigation and prompt closure of equipment-related deviations.
• Assist with 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.
• Author and review standard operating procedures and user requirement specifications for equipment.

Qualifications

• Bachelor's degree in chemical or mechanical engineering and 5 years of operations-related experience in a cGMP manufacturing environment.
• Ability to work independently with risk-based decision-making skills.
• Strong commitment to safety protocols and work practices.
• Effective in working efficiently and collaboratively within a matrix environment.

Additional experience preferred:

• Executing commissioning and validation protocols
• Asset management and work order systems (e.g., BMRAM)
• ERP systems (e.g., NetSuite, Coupa)
• Sartorius bioreactor systems, BioBrain, UNICORN, and proficiency with standalone PLC and HMI navigation

Physical Requirements

• Ability to wear PPE including gloves, protective clothing, and eye safety glasses.
• Perform physical tasks such as standing, using hands, walking, bending, kneeling, and occasionally moving materials up to 30 pounds.
• Availability to work off-hours, on-call, weekends, or in emergencies.
• Regular onsite work required.

Salary Range

$94,350 - $116,550

Benefits Offerings

Umoja Biopharma offers competitive medical, dental, and vision plans. Employees have access to a 401(k) plan through Fidelity with a 100% match up to 4% deferral, generous PTO, commuter benefits, and a cell phone stipend. For full details, visit our website benefits section.