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Sr. Manager of Maintenance and Clean Utilities

Operations: Facilities and Site Engineering | Research Triangle Park, NC | Full Time

Job Description

About Us:

Humacyte's mission is to become the leading company in novel, off-the-shelf extracellular matrix tissue products, and especially those that could provide lifesaving improvements in treatments for vascular conditions.

Humacyte, Inc., a biotechnology pioneer, discovers, develops and delivers innovative, award winning human biotherapies.  We are currently developing multiple vascular tissue engineered therapies and expanding our business model.  With a broad pipeline of potential new therapy applications, we continue to build our organization and scientific teams.

Responsibilities:

The Manager of Maintenance and Clean Utilities is responsible for developing and coordinating all mechanical, electrical, controls and metrology maintenance services to assure equipment reliability (OEE) by developing and implementing routine preventive and predictive maintenance programs. He is responsible for standardizing our preventive/predictive maintenance program and developing our maintenance workforce. The individual will also need to work closely the facilities team to assure utilities operations reliability, and the spare parts team to maintain inventory levels, qualify replacement parts and reduce spend. This role provides leadership for the facilities and biomanufacturing maintenance programs and oversight the efficient use of the computerized maintenance management system (CMMS). This position ensures the validated state of clean utilities and process equipment is properly maintained and accurate and timely cGMP documentation is completed through program ownership. These responsibilities extend to but are not limited to:

  • Supports the Executive Director of Facilities and Site Engineering
  • Always observe all safety precautions and regulations in all areas where duties are performed. Responsible for reporting all safety hazards and potential unsafe working conditions.
  • Understand and comply with of all current corporate policies and procedures.
  • Perform planned and corrective maintenance of process equipment and clean utilities systems. These systems and equipment could include areas of research, process development and bioprocessing.
  • Identify and resolve equipment and clean utilities systems malfunctions.
  • Routinely plan and organize the management of maintenance staff.  Prioritize maintenance crew's workload to maintain a compliant and safe work environment for all employees. Help develop, train and mentor Team Leads, Technicians and Operators. Create a climate in which technicians want to do their best.
  • Motivate a diverse workforce, adjust communication style to get the best results from staff. Seek input and empower others, shares ownership and visibility. Make everyone feel his/her work is important.
  • Knowledge and understanding of reliability centered maintenance practices and sound engineering practices and principles. Must consistently be generating new ideals to improve efficiency, reduce cost or eliminate waste.
  • Focus team around making reliable improvements in Overall Equipment Effectiveness (OEE). Proven ability to perform root cause analysis (RCA) and implement robust solutions to reoccurring issues.
  • Manage maintenance investigations, deviations, and corrective actions as necessary.
  • Use logic and reasoning to identify alternative solutions, conclusions, and approaches to solving equipment problems. Must have strong analytical problem-solving skills.
  • Develop, review, and/or approve maintenance SOPs, work instructions, preventative and predictive maintenance programs, calibration assessments, job plans, spare parts lists, risk assessments, and reports.
  • Administers maintenance records and coordinates the design and delivery of required technical training to employees and contractors. Document work utilizing site’s Computerized Maintenance Management System (CMMS).
  • Coordinates and directs contractor activities. Work with equipment manufacturers to procure repairs, spare parts and schedule maintenance.
  • Schedule maintenance activities with the equipment owners.  Work closely with the Biomanufacturing Supervisors and Regulatory Team to coordinate maintenance events to include resource planning, change overs, preventative maintenance and project scheduling.
  • Must possess a disciplined approach to standards and procedures required to facilitate and implement improvements. Customer focused to provide quality service and improve equipment and process reliability.
  • Must be able to identify, plan and implement process improvements in a quick and efficient manner and provide visibility of implementation progress to management.
  • Develop and maintain maintenance metrics and projections.
  • Assist in data analysis pre- and post- new equipment installation and/or project execution.

Requirements:

  • A two-year degree in Engineering, Life Sciences, other related technical field or equivalent military training.
  • Technical Certification or Associates and/or BS Degree in Mechanical, Electrical or Applied Engineering is preferred.
  • Minimum 10 years’ experience in maintaining manufacturing equipment under cGMP regimen
  • Previous team management and leadership experience

Bonus Points:

  • Skilled with routine preventive maintenance and complex troubleshooting of mechanical production equipment and clean utilities systems. 
  • Skilled with pneumatic, mechanical, and electrical instrumentation; as well as manual and computer-based process control loops and systems.
  • Advanced understanding and application of instrument, equipment, and loop calibrations of various parameters in manufacturing, utilities, and laboratory environments.
  • Advanced understanding of safety requirements and demonstrated ability to implement safe practices.
  • Advanced understanding of electrical panels and electrical safety procedures.
  • Experience managing vendors and support personnel.
  • Demonstrated experience with cGMP requirements for the lifecycle maintenance of production equipment and the documentation requirements associated with a cGMP environment.
  • Must be able to work in a team-oriented, fast-paced start-up environment and must be willing to work off-shifts, overtime and weekends as necessary for business needs.

Perks:

  • Stock Options
  • 401k Plan with Matching
  • Medical, Vision and Dental Plans
  • Long Term/Short Term Disability
  • Life Insurance
  • 3 Weeks’ Vacation
  • 5 Personal Floating Days
  • 8 Sick Days
  • 6 Company Holidays
  • Career Development and Training