Calibration Technician III

DivIHN Integration Inc; Morrisville (NC); On-site; USD 39,000 - 47,000; Full time

Job summary

DivIHN Integration Inc. is seeking a Calibration Technician III for a 12‑month engagement in Morrisville, NC. The role ensures calibration, maintenance, and repair of laboratory equipment in a GxP environment, with emphasis on documentation quality and deviation investigations under supervision.

The candidate will review vendor-supplied calibration records, ensure adherence to USP/NIST/FDA requirements, and manage CAPA/Deviation processes as needed.

Qualifications

• Bachelor's Degree or High School Diploma with required metrology experience in Pharma/Biotech.
• 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 calibration/maintenance documentation by external vendors with attention to documentation quality.
• Ensures calibration activities comply with industry regulations (USP, NIST, FDA, GLP, GMP).
• Initiates, writes, and assists investigations related to instrument calibration failures.
• Leads investigations (Deviations/CAPAs) related to instrument calibration issues.

Skills

CAPAs & Deviations (GxP)

Calibration method & tolerances

FDA regulations knowledge

Education

Bachelor's Degree

High School Diploma

Job description

For further inquiries about this opportunity, please contact our Talent Specialist, Hema Malini at [phone].

Title: Calibration Technician III Duration: 12 Months Location: Morrisville, NC

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:

• 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.

Vendor Management (Metrology):

• 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.

Team Collaboration:

• 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.

About us:

DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.

DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.