DEPARTMENT: Site Operations

LOCATION: Durham, NC; Onsite/Not Remote

JOB SUMMARY:

The Maintenance Engineer position reports to the Sr Director, Engineering and Facility Operations and provides technical leadership and subject matter expertise to support Engineering and Facilities operations, with a primary focus on equipment reliability, preventive maintenance, and clean utility systems. This role is responsible for:

• Developing and optimizing maintenance programs,
• Leading maintenance and utility-related projects,
• Ensuring the reliable, compliant, and efficient operation of facility systems.

The Maintenance Engineer serves as a key resource for Engineering and Facilities, supporting SOP development and continuous improvement initiatives, while leading or assisting with investigations, deviations, root cause analyses, and corrective and preventive actions (CAPAs). Operating with a high degree of independence, this position drives reliability improvements and supports the achievement of organizational and operational objectives.

ESSENTIAL 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.
• Ability to use AutoCAD update current Engineering Drawings and GMP dovcumentation.
• Collaborate with cross-functional teams, including Manufacturing, Quality, Validation, and EHS, to support facility and production objectives.
• Communicate project status, reliability improvement initiatives, and operational performance metrics to management and key stakeholders.

Required Skills & Knowledge

• Recognized technical expert in maintenance, facilities, and clean utility/ bioprocessing systems supporting research, development, and manufacturing operations within a cGMP biotechnology, pharmaceutical, or life sciences environment.
• Strong knowledge of cGMP regulations and lifecycle maintenance requirements for production equipment, utilities, and facility systems.
• Demonstrated experience managing maintenance programs and associated documentation in highly regulated environments.
• Experience utilizing Blue Mountain Ram 4 Computerized Maintenance Management Systems (CMMS) for asset management, maintenance planning, and reliability improvement.
• Advanced troubleshooting and problem-solving skills involving complex mechanical, electrical, utility, and process support systems.
• Strong understanding of reliability-centered maintenance (RCM), root cause analysis methodologies, and continuous improvement principles.
• Ability to lead through influence, build trust and credibility, and effectively mentor and develop team members.
• Excellent organizational, communication, and project management skills, with the ability to manage multiple priorities and drive successful outcomes across cross-functional teams.
• Ability to operate independently, exercise sound engineering judgment, and provide innovative solutions to complex technical challenges.

General Skills and Requirements

• Strong verbal and written communication skills, with the ability to effectively collaborate across all levels of the organization.
• Positive, self-motivated, and solutions-oriented mindset with strong critical thinking and problem-solving abilities.
• Ability to work effectively in a fast-paced environment with changing priorities and deadlines.
• Strong organizational, time management, and multitasking skills.
• Demonstrated ability to work successfully in cross-functional teams.
• Proficient in Microsoft Office applications, including Word, Excel, PowerPoint, and Outlook.
• Experience with AutoCAD and Engineering Drawing management.
• Adheres to company policies, SOPs, training requirements, and regulatory expectations.
• Maintains a strong commitment to safety by following all safety procedures and promptly reporting hazards or unsafe conditions.
• Represents the organization professionally and demonstrates reliable attendance and punctuality.
• Flexible to work additional hours, weekends, holidays, or alternate schedules as business needs require.

EXPERIENCE & QUALIFICATIONS:

• Associate degree in Engineering, Life Sciences, or a related technical field, or equivalent combination of education and experience required; Bachelor's degree preferred.
• Minimum of 6 years of experience supporting manufacturing equipment, facilities, and/or clean utility systems in a cGMP-regulated environment.
• Demonstrated subject matter expertise in maintenance, equipment reliability, and clean utility systems supporting manufacturing, laboratory, and utility operations.
• Strong knowledge of equipment reliability principles, and preventive maintenance programs.
• Proven experience performing root cause analysis (RCA), troubleshooting complex issues, and implementing effective corrective actions.
• Advanced understanding of safety regulations and safe work practices, with demonstrated commitment to maintaining a safe work environment.
• Strong technical writing and documentation skills, including experience authoring and reviewing SOPs, investigations, change controls, and other cGMP documentation.

COMPENSATION & BENEFITS HIGHLIGHTS:

• Stock Options
• 401k Plan with 4% Match and no Vesting Schedule
• Medical, Vision and Dental Plans
• Company Paid Long Term/Short Term Disability
• Company Paid Life Insurance
• 23 Days Paid Time Off (PTO)
• 10 Company Designated Holidays + 2 Floating Holidays
• Paid Parental Leave Policies

** Please note, Humacyte does not provide U.S. employment sponsorship and does not accept unsolicited resumes from 3rd party firms and/or agency recruiters. **

The statements in this position profile are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time.