Calibration Technician III

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

Only W2 candidates are eligible for this position. Third-party or C2C candidates will not be considered.

Job Description

• The Calibration Technician manages laboratory equipment calibrations, maintenance, and repairs, ensuring compliance with all GxP regulations. This role is responsible for the quality review of documentation and the initiation of deviation investigations related to metrology. The individual works under the supervision and direction of more senior-level roles and uses existing procedures to solve routine or standard problems

Key Responsibilities:

Calibration Execution:

• 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).

Safety and Quality Compliance:

• Adheres to all applicable written Standard Operating Procedures (SOPs), company policies, and technical guidance documents.
• Maintains training compliance in the Quality Management System.
• Initiates, writes, and assists with investigations related to instrument calibration failures or other instrument-related issues.
• Primary responsibility for the initiation, writing, and support of investigations (Deviations/CAPAs) related to instrument calibration failures or other instrument-related issues.
• Oversees and manages onsite vendors to ensure all training and compliance requirements are met for maintenance, calibration, and repairs on laboratory equipment.
• Responsible for the technical review and approval of all equipment calibration and maintenance documentation performed by external parties with a detailed eye for good documentation practices.

Asset Induction:

• Induction of new equipment, including development of calibration requirements and schedules in coordination with equipment owners and planner/ scheduler.
• Research the operating specifications of new equipment, obtain suitable standards, and establish the calibration acceptance criteria.

Documentation:

• Maintains and/or generates SOPs and controlled documents pertaining to the calibration program.
• Thoroughly documents all activities and reviews all data to ensure completeness and accuracy within the CMMS.
• Interfaces with multi-disciplinary teams regarding laboratory equipment, including lab staff, Quality Assurance, Computer Systems Validation, Facilities and Engineering, and IT.

Required 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.