Senior Calibration Technician

Job Summary:

• 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.
• Individual works under the supervision and direction of more senior-level roles and uses existing procedures to solve routine or standard problems.

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.
• Maintain 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 10+ years of metrology experience OR Bachelor’s Degree and 6+ 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.