Instrumentation & Metrology Specialist III

Role Summary

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. The primary duties center on instrument calibration and equipment controls support, with collaboration and/or assistance to the general equipment and facilities maintenance group. The ideal candidate will have advanced knowledge of GMP equipment instrumentation and controls, willingness and capability to assist with general maintenance, and the ability to collaborate with other departments as needed.

Responsibilities

• 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 and preventative maintenance calibration on GMP and 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 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 contractors executing calibration, controls and metrology activities.
• Other duties as assigned.

Qualifications

• Required: 7 years of applicable Metrology, Instrumentation or Calibration experience.
• Preferred: 7 years of Quality System / Pharmaceutical experience.
• 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).
• Must spend time in a clean room environment for manufacturing operations and meet gowning and PPE guidelines.
• Must be able to sit; stand for prolonged periods and may occasionally lift up to 20 pounds. Working holidays, weekends and overtime may be required.

Skills

• Advanced understanding and application of instrument, equipment, and loop calibrations of various parameters in manufacturing, utilities and laboratory environments.
• Knowledge of electrical panels and electrical safety procedures.
• Advanced understanding of Traceability, Substitution of Standards, and Test Accuracy and Uncertainty Ratios.
• Proficiency with pneumatic, mechanical and electrical instrumentation; manual and computer-based process control loops; understanding of calibration concepts and accuracy testing.
• Independent decision-making within defined scope of work; self-driven with ability to work with little direction.