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Senior Manager, Facilities and Maintenance

All Openings | Research Triangle Park, NC | Full Time

Job Description

**Please note, Humacyte does not provide sponsorship at this time.**

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.  We are looking for colleagues to continue to build our expanding team.

Candidates will be expected to work both independently and collaboratively as part of the Humacyte organization. Applicants must be highly self-motivated, with solid communication skills, and demonstrates the ability to work in a team environment and lead other professionals and peers.

Position Background:

The Senior Manager of Facilities and Maintenance is responsible for maintenance and facility operations in a newly retrofitted bioprocessing facility. The position is accountable for achieving business objectives that ensure the building and equipment are maintained in a state that is fit for safe use in the production of biologics by company employees, costs containment, and work performance in a manner compliant with governing regulations and cGMP practices.

Primary Responsibilities:

  • Assure all Facilities and Maintenance operations comply with all EHS and Quality policies and regulations
  • Support the development and implementation of a comprehensive maintenance and facility program for the site including supporting policies and procedures
  • Manage daily operations and the associated vendors supporting janitorial services, pest control, uniform services, landscaping and other facility management services
  • Plan and direct capital and construction management projects with the accountability for successful completion of all project deliverables to the facility within established schedule, scope, and quality objectives
  • Negotiate plans, budgets and schedules relating to facility modifications, facilities or equipment maintenance, expansions, upgrades and/or new construction
  • Assist in the development of documentation, including functional requirements, design documents, test protocols, SOPs and reports
  • Manage planned and reactive maintenance activities for the site such as preventative, predictive, corrective and emergency maintenance. Ensure reliability of equipment, efficient utilization of maintenance resources and contract maintenance services
  • Ensures the uninterrupted delivery of reliable utilities, which include steam, electric, compressed air, process gases, chilled water, etc. to the site customers in a cost-effective manner
  • Support the installation, commissioning, qualification, and validation of facility and utilities systems for commercial bioprocessing
  • Perform or assist in the execution of routine reactive and preventive maintenance activities and building automation
  • Support the troubleshooting of facilities and facility equipment for technology transfer and commercial bioprocessing
  • Assist research, process development and commercial bioprocessing as necessary
  • Work closely with vendors to provide facilities and maintenance services as needed
  • Support the activities of maintenance and utilities personnel
  • Manage departmental operating budgets
  • Support during regulatory inspections as the subject matter expert for facility, utilities, and maintenance. Support regulatory filings as required
  • Conform to the compliance with federal, state, and local regulatory authorities including FDA, EMA, OSHA, EPA, for the Facilities, Utilities and Maintenance Operations
  • Other duties, as assigned

General Competencies:

  • Possess a positive attitude and optimistic outlook
  • Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
  • Excellent organizational and time management skills with ability to set own priorities in a timely manner
  • High degree of flexibility and adaptability
  • Strong communication (verbal and written) and organizational skills
  • Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
  • Detail-oriented, self-motivated and scientifically driven
  • Motivated and organized critical thinker with solid interpersonal and communication skills
  • Strong analytical and problem-solving skills
  • Demonstrated ability to work in a cross functional team
  • Routinely communicate findings and information to other team members; transparency and knowledge sharing is expected and practiced
  • Must be able to work as needed to meet tight deadlines and at peak periods

Special Competencies:

  • Understanding of good teamwork, relationship-building, and leadership
  • Firm understanding of advanced cGMP compliance, commissioning, qualification, and validation in a biotech/bioprocessing manufacturing environment
  • Knowledge and awareness of all applicable Code of Federal Regulations
  • Exhibit and radiate energy and are comfortable in a player-coach role, with a strong commitment to transitioning Humacyte to a commercial product-driven company

QUALIFICATIONS:

  • BS in Mechanical Engineering, Electrical Engineering, Chemical Engineering, or similar field
  • At least 8 years of industry experience in facility maintenance
  • Experience in the development and operation of facilities, utilities and maintenance teams in Biotech Research, Product Development and Bioprocessing operations
  • Advanced technical experience with HVAC, boilers, chillers, and generators
  • Knowledge and experience with standard bioprocessing skills as well as use and maintenance of common laboratory procedures and equipment
  • Experience in mentoring staff in facilities operations and maintenance environments

Perks:

  • Stock Options
  • 401k Plan with Matching
  • Medical, Vision and Dental Plans
  • Long Term/Short Term Disability
  • Life Insurance
  • 23 Days Paid Time Off (PTO)
  • 11 Paid Holidays
  • Paid Parental Leave Policies

**Please note, Humacyte does not provide sponsorship at this time.**