Instrumentation & Metrology Specialist II
Humacyte · Durham, NC · 4 wk ago
ManagementFull-time
About the role
The Instrumentation and Metrology Specialist II supports the manufacturing utility and laboratory equipment at Humacyte Inc., ensuring compliance with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
Responsibilities
- Maintain and perform basic corrective and preventative maintenance calibrations on GMP and non-GMP equipment and instruments.
- Draft low-level calibration procedures and assist in the drafting of work instructions for all process and utility equipment.
- Provide recommendations for instrumentation/metrology spare parts and PM job plans.
- Assist in routing all required documentation for the submission of spare parts and PM Work Orders.
- Support other departments with minor troubleshooting, testing, repairing, and optimizing instruments, equipment, and control systems.
- Participate in 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 contractors executing calibration, controls, and metrology activities.
Requirements
- Associate’s 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 operations and will be required to meet applicable gowning and personal protective equipment guidelines.
- May occasionally be required to sit, stand for prolonged periods of time, 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.
- 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 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.
- Self-driven and demonstrates ability to work with little direction.
- 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.
Benefits
Humacyte offers a comprehensive benefits package including health insurance, retirement savings plan, paid time off, and more. Details can be found on our company website or during the hiring process.
Pay
Competitive compensation based on experience and qualifications.
Schedule
Full-time position with flexible scheduling to accommodate the needs of the department and the employee.