Calibration Technician III

For further inquiries about this opportunity, please contact our Talent Specialist, Hema Malini at View phone number on us.fitly.work.

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:
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.

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.