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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. For more information, visit www.Humacyte.com.

JOB SUMMARY:

The Instrumentation and Metrology Specialist II will provide metrology, instrumentation and controls knowledge for the manufacturing utility and laboratory equipment throughout the Humacyte site. Though the primary duties of this position will center on basic 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 intermediate knowledge of GMP equipment instrumentation and controls, willingness to assist with general maintenance, and the ability to collaborate with other departments as needed.

MAJOR ACCOUNTABILITIES

• Under the supervision and management of Instrumentation and Metrology Specialist III, will work closely with Quality, Engineering and Facilities groups to ensure strict compliance with GMP / GLP guidelines at all times, specifically to ensure that the equipment is maintained in in GMP / GLP requirements.
• Maintains and performs basic corrective, preventative maintenance calibrations on GMP and non-GMP equipment and instruments.
• Drafts low level calibration procedures and assists in the drafting of work instructions for all process and utility equipment.
• Provides 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.
• Supports other departments with minor troubleshooting, testing, repairing and optimize instruments, equipment and control systems.
• Participates in the continuous improvement efforts within the site Maintenance Program.
• 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.

REQUIREMENTS

• Associates Degree in Engineering, Life Sciences or other related technical field, required. Bachelor's degree in electrical engineering, preferred or equivalent military training.
• 3 to 5 years of applicable Metrology, Instrumentation or Calibration experience, required.
• 3 to 5 years of Quality System / Pharmaceutical experience is preferred.
• Trained in Electrical Safety NFPA-70E (144 hours of formal instruction on electrical safety, electrical system, electronics ) preferred.
• Experience utilizing a validated (Computerized Maintenance Management System / CMMS ProCal).
• Will spend time in a clean room environment for manufacturing operation 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.

SPECIFIC SKILLS

• Basic knowledge of calibration and controls disciplines within a cGMP Biotechnology / Pharmaceutical manufacturing environment, required.
• Demonstrated knowledge of DCS, PLC, and/or Building Automation Systems (BAS) control systems, required.
• Have a basic understanding and application of instrument, equipment, and loop calibrations of various parameters in manufacturing, utilities and laboratory environments.
• Basic understanding of electrical panels and electrical safety procedures.
• Listens well and asks questions to learn more.
• Familiar with control problems, troubleshooting, multimeters and oscilloscopes
• Basic 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 requirement including accuracy testing. Basic understanding and application of instrument, equipment, and loop calibrations of various parameters in manufacturing, utilities, and laboratory environments.
• Ability to make basic independent decisions within defined scope of work, seeks clarification and directions when needed. Must be self-driven and demonstrate ability to work with little direction.
• Basic experience with problem solving and troubleshooting I&C systems in a pharmaceutical environment.
• Proven knowledge of a Computerized Maintenance Management System (CMMS).
• Strong organization and planning skills required.
• Excellent interpersonal effectiveness and communication skills (written and oral) are required to interface across management levels and departments.
• Ensures safe work practices are followed at all times.

The statements in this position profile are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time. Humacyte is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, Humacyte is committed to achieving its business objectives in compliance with all federal, state and local law.