Calibration Technician V

DivIHN Integration•Morrisville, NC

1d•Onsite

About The Position

The Calibration Technician manages laboratory equipment calibrations, maintenance, and repairs while ensuring compliance with applicable GxP regulations. The role performs quality reviews of documentation and initiates deviation investigations related to metrology. The technician works under the supervision and direction of more senior-level roles and uses established procedures to solve routine or standard problems. The position independently performs maintenance, calibration, and repairs on active equipment, including loop calibrations. It also oversees onsite metrology vendors, reviews vendor documentation, and supports the induction of new equipment by establishing calibration requirements, schedules, standards, and acceptance criteria. The technician maintains and generates calibration-program SOPs and controlled documents, records and reviews data in the CMMS, and collaborates with laboratory, quality, validation, facilities, engineering, and IT teams.

Requirements

High school diploma and 10 or more years of metrology experience, or a bachelor’s degree and 6 or more years of metrology experience in the pharmaceutical/biotechnology industry.
Experience investigating and completing CAPAs and deviations in a GxP environment.
Strong understanding of calibration methodology, tolerances, and FDA regulations.

Responsibilities

Independently perform maintenance, calibration, and repairs on active equipment, including loop calibrations.
Review and approve external vendors’ equipment calibration and maintenance documentation, ensuring good documentation practices.
Ensure calibration activities comply with relevant regulations and standards, including USP, NIST, FDA, GLP, and GMP.
Follow applicable SOPs, company policies, and technical guidance documents, and maintain training compliance in the Quality Management System.
Initiate, write, and support investigations, including deviations and CAPAs, related to calibration failures or other instrument-related issues.
Oversee onsite metrology vendors and ensure they meet training and compliance requirements for equipment maintenance, calibration, and repairs.
Induct new equipment, including developing calibration requirements and schedules in coordination with equipment owners and the planner/scheduler.
Research new equipment operating specifications, obtain suitable standards, and establish calibration acceptance criteria.
Maintain and generate SOPs and controlled documents for the calibration program.
Document activities and review data for completeness and accuracy in the CMMS.
Interface with laboratory staff, Quality Assurance, Computer Systems Validation, Facilities and Engineering, and IT regarding laboratory equipment.