Instrumentation & Metrology Specialist III

Job Summary

DEPARTMENT: Site Operations
LOCATION: Durham, NC;
Onsite/Not Remote
COMPANY: Humacyte Inc (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s initial opportunity, a portfolio of Acellular Tissue Engineered Vessel (ATEVs), is currently approved for use in vascular trauma repair and is in late-stage clinical trials targeting multiple other applications including AV access for hemodialysis and peripheral arterial disease.

Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma also received the RMAT designation.

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• Partner with Quality, Engineering and Operations groups to ensure strict compliance with GMP / GLP guidelines at all times, specifically to ensure that the equipment is maintained in GMP / GLP requirements.
• Lead, maintain, and perform basic and advanced corrective, preventative maintenance calibration on GMP and non-GMP equipment and instruments.
• Draft all calibration procedures needed and assists in the drafting of 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.
• Site Subject Matter Expert to troubleshoot, test, repair and optimize instruments, equipment and control systems.
• Provide I&C expertise and guidance in the Capital design, appropriation, and installation processes.
• Collaborate with all departments in the 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 contractor executing calibration, controls and metrology activities.
• Other duties as assigned.

• Degree in Engineering, Life Sciences or other related technical field, or equivalent military training preferred.
• 7 years of applicable Metrology, Instrumentation or Calibration experience required.
• 7 years of Quality System / Pharmaceutical experience is preferred.
• Instrumentation Technical Training Certificate (ISA-CCST) or equivalent preferred.
• Trained in electrical safety NFPA-70E (144 hours of formal instruction on electrical safety, electrical systems, electronics) preferred.
• Will spend time in a clean room environment for manufacturing operations and will be required to meet applicable gowning and personal protective equipment guidelines.
• Will be required to regularly sit; stand for prolonged periods of time. Also, may occasionally be required to pull, lift and/or move up to 20 pounds.
• Position may require working holidays, weekends and overtime.

• Advance understanding and application of instrument, equipment, and loop calibrations of various parameters in manufacturing, utilities and laboratory environments.
• Proven knowledge and understanding of electrical panels and electrical safety procedures.
• Advance understanding of Traceability, Substitution of Standards, and Test Accuracy and Uncertainty Ratios.
• Skilled with pneumatic, mechanical and electrical instrumentation; as well as manual and computer-based process control loops and systems; understands and applies basic concepts of calibration and requirements including accuracy testing. Advance understanding and application of instrument, equipment, and loop calibrations of various…