{"id":1644083,"url":"https://alion.io/job/humacyte-maintenance-engineer","title":"Maintenance Engineer","company":{"id":2472022,"name":"Humacyte","domain":"humacyte.com","url":"https://alion.io/company/humacyte","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"ADP","truth_index":null},"role":"Field & Service","role_family":"Field & Service","seniority":"senior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Durham, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":52000,"max_usd":101000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":3331},"experience_years_min":6,"visa_sponsorship":false,"relocation_package":false,"has_equity":true,"technologies":[{"name":"AutoCAD","optional":false},{"name":"GMP","optional":false},{"name":"Mandiant capa","optional":false},{"name":"Microsoft Office","optional":false},{"name":"Outlook","optional":false}],"status":"live","first_seen_at":"2026-09-15T17:06:00Z","employer_posted_date":"2026-09-15","last_verified_at":"2026-10-21T08:24:25Z","board_verified":true,"closed_at":null,"days_open":35,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":35},"description":"DEPARTMENT: Site Operations\nLOCATION: Durham, NC; Onsite/Not Remote\nCOMPANY: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. For more information, visit www.Humacyte.com.\n________________________________________________________________________________________________________________\nJOB SUMMARY:\nThe 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:\nDeveloping and optimizing maintenance programs,\nLeading maintenance and utility-related projects, \nEnsuring the reliable, compliant, and efficient operation of facility systems. \nThe 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.\nESSENTIAL RESPONSIBILITIES:\nPromote and ensure compliance with all company safety policies, procedures, and regulatory requirements, fostering a culture of safety throughout Engineering and Facilities operations.\nServe 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.\nHelp oversee the necessary spare parts program to ensure critical replacement parts are in stock for necessary equipment repairs. \nLead initiatives to improve equipment reliability, maintainability, and Overall Equipment Effectiveness (OEE) through data-driven analysis and continuous improvement methodologies.\nIdentify and implement process improvements that enhance efficiency, reduce costs, eliminate waste, and increase system performance.\nSupport 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.\nLead or support maintenance investigations, deviations, root cause analyses, and corrective and preventive action (CAPA) activities to ensure timely resolution and regulatory compliance.\nWork 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.\nAbility to use AutoCAD update current Engineering Drawings and GMP dovcumentation.\nCollaborate with cross-functional teams, including Manufacturing, Quality, Validation, and EHS, to support facility and production objectives.\nCommunicate project status, reliability improvement initiatives, and operational performance metrics to management and key stakeholders.\nRequired Skills & Knowledge\nRecognized 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.\nStrong knowledge of cGMP regulations and lifecycle maintenance requirements for production equipment, utilities, and facility systems.\nDemonstrated experience managing maintenance programs and associated documentation in highly regulated environments.\nExperience utilizing Blue Mountain Ram 4 Computerized Maintenance Management Systems (CMMS) for asset management, maintenance planning, and reliability improvement.\nAdvanced troubleshooting and problem-solving skills involving complex mechanical, electrical, utility, and process support systems.\nStrong understanding of reliability-centered maintenance (RCM), root cause analysis methodologies, and continuous improvement principles.\nAbility to lead through influence, build trust and credibility, and effectively mentor and develop team members.\nExcellent organizational, communication, and project management skills, with the ability to manage multiple priorities and drive successful outcomes across cross-functional teams.\nAbility to operate independently, exercise sound engineering judgment, and provide innovative solutions to complex technical challenges.\nGeneral Skills and Requirements\nStrong verbal and written communication skills, with the ability to effectively collaborate across all levels of the organization.\nPositive, self-motivated, and solutions-oriented mindset with strong critical thinking and problem-solving abilities.\nAbility to work effectively in a fast-paced environment with changing priorities and deadlines.\nStrong organizational, time management, and multitasking skills.\nDemonstrated ability to work successfully in cross-functional teams.\nProficient in Microsoft Office applications, including Word, Excel, PowerPoint, and Outlook.\nExperience with AutoCAD and Engineering Drawing management.\nAdheres to company policies, SOPs, training requirements, and regulatory expectations.\nMaintains a strong commitment to safety by following all safety procedures and promptly reporting hazards or unsafe conditions.\nRepresents the organization professionally and demonstrates reliable attendance and punctuality.\nFlexible to work additional hours, weekends, holidays, or alternate schedules as business needs require.\nEXPERIENCE & QUALIFICATIONS:\n· Associate degree in Engineering, Life Sciences, or a related technical field, or equivalent combination of education and experience required; Bachelor's degree preferred. \n· Minimum of 6 years of experience supporting manufacturing equipment, facilities, and/or clean utility systems in a cGMP-regulated environment. \n· Demonstrated subject matter expertise in maintenance, equipment reliability, and clean utility systems supporting manufacturing, laboratory, and utility operations. \n· Strong knowledge of equipment reliability principles, and preventive maintenance programs. \n· Proven experience performing root cause analysis (RCA), troubleshooting complex issues, and implementing effective corrective actions. \n· Advanced understanding of safety regulations and safe work practices, with demonstrated commitment to maintaining a safe work environment. \n· Strong technical writing and documentation skills, including experience authoring and reviewing SOPs, investigations, change controls, and other cGMP documentation.\nCOMPENSATION & BENEFITS HIGHLIGHTS:\nStock Options\n401k Plan with 4% Match and no Vesting Schedule\nMedical, Vision and Dental Plans\nCompany Paid Long Term/Short Term Disability\nCompany Paid Life Insurance\n23 Days Paid Time Off (PTO)\n10 Company Designated Holidays + 2 Floating Holidays\nPaid Parental Leave Policies\n\n** Please note, Humacyte does not provide U.S. employment sponsorship and does not accept unsolicited resumes from 3rd party firms and/or agency recruiters. **\nThe 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. Humacyte is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. 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