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Manager, Instrumentation & Metrology

HUMACYTE GLOBAL INC

Durham, NCOnsitePosted 47 days ago
Full TimeSenior LevelManufacturing & CMCBiotechnology
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Summary

The Manager, Metrology & Instrumentation department is responsible for oversight of Metrology Services, including performing calibrations, preventive maintenance, general repairs, and troubleshooting. This role involves delegating tasks, developing and motivating the team to achieve organizational goals, and performing all aspects of personnel leadership including staffing strategy, recruitment, performance management, professional development, and retention. The manager ensures equipment reliability (OEE) through development and implementation of routine preventative and predictive metrology programs, leads the team providing planned and unplanned support to functional areas, ensures adherence to compliance requirements, and ensures observance of safety precautions and regulations.

Job description

Job Summary

The Manager, Metrology & Instrumentation department is responsible for oversight of Metrology Services, including performing calibrations, preventive maintenance, general repairs, and troubleshooting. This role involves delegating tasks, developing and motivating the team to achieve organizational goals, and performing all aspects of personnel leadership including staffing strategy, recruitment, performance management, professional development, and retention. The manager ensures equipment reliability (OEE) through development and implementation of routine preventative and predictive metrology programs, leads the team providing planned and unplanned support to functional areas, ensures adherence to compliance requirements, and ensures observance of safety precautions and regulations.

Essential Functions

  • Delegate and assign day-to-day activities of team members while motivating the team to achieve goals and KPIs
  • Empower team members with skills to improve confidence, product knowledge, and communication skills
  • Responsible for deciding how to approach tasks and develop a plan for the team to accomplish them
  • Partner with Quality, Engineering and Operations groups to ensure strict compliance with GMP/GLP guidelines, specifically to ensure equipment is maintained in GMP/GLP requirements
  • Lead, maintain, and perform basic and advanced corrective, preventative maintenance calibrations on GMP & non-GMP equipment and instruments
  • Draft all calibration procedures needed and assist in drafting work instructions for all process and utility equipment
  • Research and provide informed recommendations for instrumentation/metrology spare parts and PM job plans
  • Assist in routing all required documentation for the submittal of spare parts and PM WOs
  • Serve as Subject Matter Expert (SME) to troubleshoot, test, repair and optimize instruments, equipment, and control system
  • Provide I&C expertise and guidance in the Capital design, appropriation, and installation processes
  • Collaborate with all departments in continuous improvement efforts within the site Maintenance Program
  • Oversee and assist in the maintenance and review of calibration standards and vendor calibration documentation
  • Work with contract service providers and support contractors executing calibration, controls and metrology activities
  • Other duties as assigned

Experience & Qualifications

  • Associate's degree in engineering, Life Sciences or other related technical field required
  • Bachelor's degree in electrical engineering preferred, or equivalent training from a military environment
  • 7 years of applicable Metrology, Instrumentation and/or Calibration experience required
  • Proven leadership experience leading a team of Metrology specialists
  • Subject Matter Expert in metrology and instrumentation maintenance services to assure equipment reliability in manufacturing, utilities and laboratory environments
  • Trained in Electrical Safety NFPA-70E (144 hours of formal instruction on electrical safety is preferred)
  • Experience with working in a clean room environment for manufacturing operations and will be required to meet applicable gowning and PPE guidelines
  • Required to regularly sit; stand for prolonged periods of time. May be occasionally required to pull, lift and/or move up to 20 pounds
  • Excellent communication and interpersonal skills

Requirements

  • Associate's degree in engineering, Life Sciences or other related technical field required
  • Bachelor's degree in electrical engineering preferred, or equivalent training from a military environment
  • 7 years of applicable Metrology, Instrumentation and/or Calibration experience required
  • Proven leadership experience leading a team of Metrology specialists
  • Subject Matter Expert in metrology and instrumentation maintenance services to assure equipment reliability in manufacturing, utilities and laboratory environments
  • Trained in Electrical Safety NFPA-70E (144 hours of formal instruction on electrical safety is preferred)
  • Experience with working in a clean room environment for manufacturing operations and will be required to meet applicable gowning and PPE guidelines
  • Excellent communication and interpersonal skills

Benefits

  • Stock Options
  • 401(k) Matching
  • Medical, Dental & Vision
  • Long Term Disability
  • Short Term Disability
  • Life Insurance
  • Paid Time Off
  • Paid Parental Leave

Company overview

Humacyte Global Inc. (Nasdaq: HUMA) is a pioneering biotechnology company specializing in regenerative medicine and tissue engineering. Founded in 2004 and headquartered in Durham, North Carolina, the company has developed a groundbreaking bioengineering platform that creates universally implantable, acellular tissue engineered vessels (ATEV™). In December 2024, Humacyte achieved a significant milestone when the FDA granted full approval for its first product, Symvess™, an acellular tissue engineered vessel for extremity arterial trauma repair. This represents the first FDA-approved, human-derived biologic vessel for vascular injury treatment. The company's innovative platform transforms human cells into off-the-shelf regenerative tissues designed to be universally implantable and capable of remodeling with the patient's own cells over time. Humacyte's technology is being investigated for multiple clinical applications including arteriovenous access for hemodialysis, peripheral arterial disease, coronary artery bypass grafts, and treatment of type 1 diabetes. With over 215 employees, the company continues to advance its mission of engineering regenerative medicine products to save and improve patient lives through bioengineered human tissues and organs.

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