Calibration Technician

AskBio•Morrisville, NC

2d•Onsite

About The Position

The Calibration Technician manages laboratory equipment calibrations, maintenance, and repairs while ensuring compliance with GxP regulations. Working under the supervision and direction of more senior-level roles, the technician uses established procedures to solve routine or standard problems. The position performs equipment and loop calibrations, reviews vendor documentation, initiates and supports metrology-related investigations, and maintains calibration program documentation and records. The technician also coordinates the induction of new equipment and collaborates with laboratory, quality, validation, facilities, engineering, and IT teams.

Requirements

High school diploma and 10 years of metrology experience, or a bachelor's degree and 6 years of metrology experience in the pharmaceutical or 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 applicable industry regulations, including USP, NIST, FDA, GLP, and GMP requirements.
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.
Coordinate induction of new equipment, including development of calibration requirements and schedules with equipment owners and the planner/scheduler.
Research new equipment operating specifications, obtain suitable standards, and establish calibration acceptance criteria.
Maintain or 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.