Automation Engineer III

Job Description

DEPARTMENT: Site Operations

LOCATION: Durham, NC;
Onsite/Not Remote

COMPANY: Humacyte Inc (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s initial opportunity, a portfolio of Acellular Tissue Engineered Vessel (ATEVs), is currently in late-stage clinical trials targeting multiple vascular applications, including vascular trauma repair, AV access for hemodialysis, and peripheral arterial disease.

Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma also has received an RMAT designation.

The ATEV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit

JOB SUMMARY:

The Automation Engineer III is responsible for executing and/or supporting any existing and new project automation systems at Humacyte, an FDA regulated site. This includes daily verifications required for data integrity requirements and modifications to the system configuration as required for process, building or historian automation requirements. There is an expectation that the employee will have a primary system responsibility, either DeltaV, PLC, BAS, or PI focused, but will be able to support all automation system as required.

ESSENTIAL FUNCTIONS:

• Utilizing current engineering skills and knowledge, provide routine & non-routine automation expertise for the development of custom commercial manufacturing equipment for a human acellular vessel product with the guidance and direction of more senior team members and/or manager
• Build on knowledge and expertise through supporting and maintaining an existing PI data historian in existing manufacturing and R&D facilities
• In collaboration with Senior Automation Engineer and/or Associate Director, Automation, manage the installation and validation of a PI data historian for the commercial manufacturing facility
• Act as systems expert, by supporting the installation and validation of a DeltaV system, building automation system, OEM and custom PLCs for the commercial manufacturing process
• Partner with process development team in testing prototype equipment and by owning the automation projects to for custom research and development equipment
• Promote transparency around process development activities through routine internal updates to direct manager and/or cross-functional colleagues
• As the system expert, support and troubleshoot automation during development, technology transfer, and commercial manufacturing
• Design and perform thorough system tests to ensure robustness of custom automation
• Support in oversight of the transition of automated equipment to comply with regulatory and quality control requirements
• Responsible for or assist AD, Automation/Sr. Automation Engineer in the development of routine automation documentation, including functional requirements, design documents, test protocols, SOPs and reports
• Respond to automation-based alarms during standard office hours and act as on-call support, as required
• Work cross functionally with other teams and departments by communicating subject matter expertise
• Represent Automation Team in projects or meetings, as necessary or assigned
• Support regulatory filings as required
• Other Duties as assigned.

EXPERIENCE &

QUALIFICATIONS:

• Bachelor’s degree, required. In Mechanical Engineering, Electrical Engineering, Chemical Engineering, or similar field, preferred
• 5-8 years of industry experience in process and equipment automation
• At…