Instrumentation & Metrology Specialist III

Job Description

Job Description

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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The Instrumentation and Metrology Specialist III will provide metrology, instrumentation and controls knowledge and expertise for manufacturing, utility and laboratory equipment throughout the Humacyte site. Though the primary duties of this position will center on instrument calibration and equipment controls support, the position may be required to collaborate and / or assist with the general equipment and facilities maintenance group. The ideal candidate will display an advanced knowledge of GMP equipment instrumentation and controls, willingness and expertise to assist with general maintenance, and the ability to collaborate with other departments as needed.

• 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.
• Leads, maintains, and performs basic and advance corrective, preventative maintenance calibration on GMP and non-GMP equipment and instruments.
• Drafts all calibration procedures needed and assists in the drafting of work instructions for all process and utility equipment.
• Research and provides informed recommendations for instrumentation / metrology spare parts and PM job plans.
• Assists 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.
• Provides 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.
• Oversees and assists in the maintenance and review of calibration standards and vendor calibration documentation.
• Works 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 to sit; stand for prolonged periods of time. Also, may…