Biotech Maintenance Engineer – Reliability & Clean Utilities

Humacyte Global Inc; Durham (NC); On-site; USD 95,000 - 125,000; Full time

Benefits offered by this job

Stock Options

401k Plan with 4% Match

Medical, Vision and Dental Plans

Paid Time Off 23 Days+

Job summary

Humacyte Inc is seeking a Maintenance Engineer to provide technical leadership for equipment reliability, preventive maintenance, and clean utility systems within a cGMP setting. You will drive maintenance programs, oversee CAPAs, and improve OEE while collaborating with Manufacturing, Quality, Validation and EHS to meet facility and production goals.

The role emphasizes independent work, SOP development, and steady improvements in reliability, safety, and regulatory compliance.

Qualifications

• Maintenance, facilities and clean utility systems in a cGMP-biotech environment.
• Experience managing maintenance programs and documentation in regulated settings.
• Strong knowledge of safety, regulatory requirements, and SOPs.

Responsibilities

• Promote compliance with safety policies, regulatory requirements and a culture of safety.
• Serve as SME for maintenance and clean utility systems and troubleshoot equipment failures.
• Oversee spare parts program to ensure critical replacements are in stock.
• Lead reliability improvements and OEE initiatives using data-driven methods.
• Identify process improvements to increase efficiency and reduce costs.
• Support SOPs, drawings, work instructions and change controls.
• Lead or support CAPA investigations and root cause analyses.
• Collaborate with cross-functional teams to support facility and production objectives.
• Communicate project status and performance metrics to management.

Skills

Maintenance expertise

Facilities

RCM

Root cause analysis

Project management

Cross-functional collaboration

Safety awareness

Technical writing

Education

Associate degree in Engineering/Life Sciences or related field

Bachelor’s degree preferred

Tools

AutoCAD

Blue Mountain Ram 4 CMMS

Job description

Humacyte Inc is seeking a Maintenance Engineer to provide technical leadership for equipment reliability, preventive maintenance, and clean utility systems within a cGMP setting. You will drive maintenance programs, oversee CAPAs, and improve OEE while collaborating with Manufacturing, Quality, Validation and EHS to meet facility and production goals.

The role emphasizes independent work, SOP development, and steady improvements in reliability, safety, and regulatory compliance.