Senior Calibration Technician

Job Description

Job Summary:

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

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• Independently performs maintenance, calibration, and repairs on active equipment, including loop calibrations.
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• Reviews and approves equipment calibration and maintenance documentation performed by external vendors with a detailed eye for good documentation practices.
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• Ensures all calibration activities comply with relevant industry regulations (e.g., USP, NIST, FDA, GLP, GMP).
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Safety and Quality Compliance:

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• Adheres to all applicable written Standard Operating Procedures (SOPs), company policies, and technical guidance documents.
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• Maintain training compliance in the Quality Management System.
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• Initiates, writes, and assists with investigations related to instrument calibration failures or other instrument related issues.
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• Primary responsibility for the initiation, writing, and support of investigations (Deviations/CAPAs) related to instrument calibration failures or other instrument-related issues.
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Vendor Management (Metrology):

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• Oversees and manages onsite vendors to ensure all training and compliance requirements are met for maintenance, calibration, and repairs on laboratory equipment.
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• 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.
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Asset Induction:

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

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• Maintains and/or generates SOPs and controlled documents pertaining to the calibration program.
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• Thoroughly documents all activities and reviews all data to ensure completeness and accuracy within the CMMS.
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Team Collaboration:

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• Interfaces with multi-disciplinary teams regarding laboratory equipment including, lab staff, Quality Assurance, Computer Systems Validation, Facilities and Engineering, and IT.
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Required Qualifications:

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• High School Diploma and 10+ years of metrology experience OR Bachelor’s Degree and 6+ years of metrology experience in the Pharma/Biotech industry.
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• Experience investigating and completing CAPAs and deviations in a GxP environment.
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• Strong understanding of calibration methodology, tolerances, and FDA regulations.
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