Calibration Technician III

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).
• Adheres to all applicable written Standard Operating Procedures (SOPs), company policies, and technical guidance documents.
• Maintain training compliance in the Quality Management System.
• Initiates, writes, and assists with investigations 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.
• 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.
• 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

• A High School Diploma and 6+ years of metrology experience OR a 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.
• A strong understanding of calibration methodology, tolerances, and FDA regulations.