Instrumentation & Metrology Specialist III

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.

Major Accountabilities

• 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.

Requirements

• Associates Degree in Engineering, Life Sciences or other related technical field, required.
• Bachelor's in Electrical Engineering, preferred, or equivalent military training.
• 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 occasionally be required to pull, lift and/or move up to 20 pounds.
• Position may require working holidays, weekends and overtime.

Specific Skills

• 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 parameters in manufacturing, utilities, and laboratory environments.
• General electrical panel knowledge and electrical safety procedures.
• Able to make 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.