Calibration Technician V

About the role

This role supports the laboratory equipment at a pharmaceutical and biotech organization's drug discovery research site in the Research Triangle, keeping instruments calibrated, documented, and compliant so research work can run without interruption.

Skills

• Laboratory instrument and loop calibration to NIST and USP traceable standards
• GxP deviation and CAPA investigation writing for calibration failures
• CMMS-based calibration program management, including scheduling, asset induction, and acceptance criteria

Responsibilities

• Perform calibration, maintenance, and repairs on active laboratory equipment, including loop calibrations
• Review and approve calibration and maintenance records from outside vendors for good documentation practices
• Keep all calibration work compliant with USP, NIST, FDA, GLP, and GMP requirements
• Initiate, write, and support deviations and CAPAs tied to calibration failures and instrument issues
• Oversee onsite calibration vendors and confirm their training and compliance requirements are met
• Bring new equipment into the program by researching specifications, sourcing standards, and setting acceptance criteria and schedules
• Write and maintain SOPs and controlled documents for the calibration program
• Document all activity and review data for accuracy in the CMMS
• Work with lab staff, QA, Computer Systems Validation, Facilities, Engineering, and IT on equipment issues

Requirements

• High school diploma with 10+ years of metrology experience, or a bachelor's degree with 6+ years of metrology experience in pharma or biotech
• Hands-on experience investigating and closing deviations and CAPAs in a GxP environment
• Solid command of calibration methodology, tolerances, and FDA regulations
• Ability to work fully onsite in Morrisville, NC

Preferred qualifications

• Experience writing calibration SOPs and controlled documents
• Experience overseeing third-party calibration vendors
• Experience inducting new laboratory equipment and setting calibration acceptance criteria
• Experience working alongside Computer Systems Validation teams