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Director of Engineering

Operations | 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:

  • Responsible for all engineering, maintenance, utility and facility operations, metrology, EHS, and capital projects in a newly retrofitted bioprocessing facility.  The position is accountable for achieving business objectives that ensure the building and equipment are designed and maintained in a state that is fit for safe use in the manufacture of drug product by company employees, project and maintenance schedules are adhered to, costs are contained, and work is performed in a manner that is compliant with governing regulations and cGMP practices.  These responsibilities include, but are not limited to:

    • Develops, implements and owns a comprehensive engineering, maintenance and facility program for the site, to include staffing both internal and external, planning, parts management, and supporting policies and procedures.

    • Oversees all planned and demand maintenance activities for the site such as preventative, predictive, corrective and emergency maintenance. This includes ensuring reliability of equipment, efficient utilization of maintenance resources, sourcing and inventory management of maintenance parts and materials, and contract maintenance services.

    • Responsible to apply best practices for equipment lifecycle management to include programs and metrics needed to achieve a world class OEE.

    • Ensures the delivery of reliable utilities, which include steam, electric, compressed air, process gases, chilled water, etc. to the site customers in a cost-effective manner.

    • Directs the activities of engineering, maintenance and utilities personnel, managing departmental operating and capital budgets, in addition to the site capital budget planning and tracking.

    • Develops and implements capital plans, which includes defining scope with customers, design and detailed engineering, project cost estimation, submitting appropriate justification and funding requests, and adhering to cGMP, budget, schedule, safety, and quality commitments.

    • Represents Facilities and Engineering function during regulatory inspections as the subject matter expert for facility, utilities, and maintenance.

    • Responsible for compliance with federal, state, and local regulatory authorities including FDA, EMA, OSHA, EPA, etc.

    • Collaborates with the Manufacturing/Validation/Quality leaders to develop the plan to implement consistent, cost-effective, supportable automation technology solutions and standards.

    • Responsible for oversight of engineering vendor selection and management including: development of RFQ’s, cost estimates, bid selection, invoice approval, and schedule development and maintenance.

    • Develops, implements, staffs, and owns a safety program for the facility compliant with federal, state, and local regulations.

    • Ensures the company's commitment to maintain a safe workplace and to protect the environment through the establishment of company policies and procedures.

    • Ensures effective, timely communication both written and verbal to internal teams and external customers, contractors and agencies.

    • Assists in the development and maintenance of a business culture, which supports the Company's overall business objectives and goals, by providing leadership in issues that involve “cost, quality, process, schedule and people”.

Requirements:

  • Process Knowledge
    • Advanced understanding of contamination control topics including cleanroom operation, maintenance, HEPA filtration, disinfection, gowning, and proper material/personnel flow
    • Advanced knowledge with pharmaceutical industry guidelines such as ISPE Baseline Guides, ISO and ASME BPE
    • Possesses firm understanding of equipment and procedures, and identifies potential problems before they occur
    • Advanced understanding of facilities and utilities utilized in pharmaceutical manufacturing environment
  • Problem Solving:
    • Critical thinker
    • Able to develop and implement preventative action plans to non-obvious problems, and can confidently deal with corrective actions
    • Acts as a potential downstream resource for process development, and participates in long term strategic process development as needed
  • Communication:
    • Effectively communicates downstream, manufacturing process engineering concepts to both executive and scientific leadership.
    • Strong oral and written communication skills. Capable of writing management level reports and summaries.  Clearly communicates scientific and process issues with co-workers and supervision, and communicates in a timely manner.
  • Budget and financials
    • Effectively manages operating budgets and effectively and regularly communicates status to the management team.

Minimum Requirements:

  • Extensive industry experience, 15+ years preferred
  • Minimum Bachelor’s Degree in Engineering (e.g. Mechanical, Chemical, Electrical, or Industrial)
  • Substantial experience with cGMP facility design, build, qualification, and maintenance
  • Experience with large capital projects
  • Direct experience with regulatory, OSHA, EPA, etc. inspections
  • Highly-motivated and organized
  • Works and leads well in a team environment

Bonus Points:

  • Experience with design and operation of commercial cell culture processes.
  • Demonstrated understanding or leadership in a broad spectrum of bioprocess applications, leadership experience in mentoring staff a plus.
  • Advanced understanding of fluid mechanics, mass transfer, and mechanical design.
  • Experienced leader of commissioning, qualification, and validation in a cGMP environment.
  • Demonstrated history of working with design, construction, and engineering firms.
  • Demonstrated experience with cGMP requirements for the lifecycle maintenance of production equipment and the documentation requirements associated with a cGMP environment.

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