Maintenance Engineer

About the role

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 approved for use in vascular trauma repair and is in late-stage clinical trials targeting multiple other applications including 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 received the RMAT designation.

Responsibilities

• Promote and ensure compliance with all company safety policies, procedures, and regulatory requirements, fostering a culture of safety throughout Engineering and Facilities operations.
• Serve as the Subject Matter Expert (SME) for maintenance and clean utility systems, providing technical leadership to identify, troubleshoot, and resolve equipment and system failures while minimizing operational downtime.
• Help oversee the necessary spare parts program to ensure critical replacement parts are in stock for necessary equipment repairs.
• Lead initiatives to improve equipment reliability, maintainability, and Overall Equipment Effectiveness (OEE) through data-driven analysis and continuous improvement methodologies.
• Identify and implement process improvements that enhance efficiency, reduce costs, eliminate waste, and increase system performance.
• Support the development, review, approval, and continuous improvement of Engineering and Facilities Standard Operating Procedures (SOPs), Engineering drawings, work instructions, quality events, change controls, risk assessments, and related documentation.
• Lead or support maintenance investigations, deviations, root cause analyses, and corrective and preventive action (CAPA) activities to ensure timely resolution and regulatory compliance.
• Work closely with the CMMS administrator to optimize Blue Mountain Ram 4 Computerized Maintenance Management System (CMMS) to manage maintenance activities, asset history, work orders, preventive maintenance programs, and performance metrics