Senior Calibration Technician — GMP & QA Metrology Expert

DivIHN Integration Inc; Morrisville (NC); On-site; USD 70,000 - 90,000; Full time

Job summary

DivIHN Integration Inc is seeking a Calibration Technician in Morrisville, NC to manage calibration, maintenance, and repair of laboratory equipment in a GxP environment.

The role requires reviewing documentation, ensuring compliance with USP, NIST, FDA, GLP, GMP, and leading investigations into instrument-related deviations. The candidate must bring significant metrology experience in pharma/biotech and a strong quality mindset.

Qualifications

• High School Diploma and 6+ years of metrology experience OR Bachelor’s Degree and 2+ years of metrology experience in the Pharma/Biotech industry.
• Experience investigating and completing CAPAs and deviations in a GxP environment.
• Strong understanding of calibration methodology, tolerances, and FDA regulations.

Responsibilities

• Independently performs maintenance, calibration, and repairs on active equipment, including loop calibrations.
• Reviews and approves equipment calibration and maintenance documentation performed by external vendors with a detailed eye for good documentation practices.
• Ensures all calibration activities comply with relevant industry regulations (e.g., USP, NIST, FDA, GLP, GMP).
• Adheres to all applicable SOPs, policies, and guidance documents.
• Maintains training compliance in the Quality Management System.
• Initiates and assists investigations related to instrument calibration failures or other instrument-related issues (Deviations/CAPAs).
• Oversees onsite vendors to ensure training and compliance for calibration activities.
• Technical review and approval of calibration/maintenance documentation.

Skills

CAPA investigations

GxP compliance

Calibration methodology

FDA regulations

Documentation review

Education

Bachelor’s Degree in Pharma/Biotech

High School Diploma

Job description

DivIHN Integration Inc is seeking a Calibration Technician in Morrisville, NC to manage calibration, maintenance, and repair of laboratory equipment in a GxP environment.

The role requires reviewing documentation, ensuring compliance with USP, NIST, FDA, GLP, GMP, and leading investigations into instrument-related deviations. The candidate must bring significant metrology experience in pharma/biotech and a strong quality mindset.