Calibration Technician

Job Title: Calibration Technician

Client Overview

You would be joining the laboratory operations group at a pharmaceutical and biotechnology organization working in an FDA regulated, GxP controlled environment. The site runs a formal calibration and metrology program covering active lab instrumentation, supported by both internal staff and onsite external service vendors. This position sits at the intersection of lab operations, Quality Assurance, and Facilities and Engineering.

Top 3 Skills

• Equipment calibration and metrology in a regulated lab, including loop calibrations, tolerances, and establishing acceptance criteria
• Authoring and supporting GxP investigations, deviations and CAPAs, tied to instrument and calibration failures
• Calibration program documentation and recordkeeping in a CMMS, including technical review of vendor executed work

What You'll Do

• Perform maintenance, calibration, and repair on active lab equipment, including loop calibrations
• Technically review and approve calibration and maintenance documentation executed by external vendors, applying good documentation practices
• Initiate, write, and support deviations and CAPAs tied to instrument calibration failures and other instrument issues
• Oversee onsite vendors and confirm their training and compliance requirements are met
• Induct new equipment, developing calibration requirements and schedules with equipment owners and the planner or scheduler
• Research operating specifications for new equipment, obtain suitable standards, and establish calibration acceptance criteria
• Maintain and author SOPs and controlled documents supporting the calibration program
• Document all activities in the CMMS and review data for completeness and accuracy
• Confirm calibration activities stay compliant with applicable regulations and standards, including USP, NIST, FDA, GLP, and GMP
• Work across lab staff, Quality Assurance, Computer Systems Validation, Facilities and Engineering, and IT

What We Need From You

• High school diploma with 6 or more years of metrology experience, or a bachelor's degree with 2 or more years of metrology experience in pharma or biotech
• Hands on calibration experience across lab instrumentation, including loop calibrations
• Experience investigating and completing deviations and CAPAs in a GxP environment
• Working knowledge of calibration methodology, tolerances, and FDA regulations
• Experience documenting calibration and maintenance activity in a CMMS or equivalent asset management system

Preferred / Bonus

• Experience with a specific CMMS platform such as Blue Mountain RAM, Maximo, or SAP PM
• Experience managing or auditing third party calibration service vendors
• Familiarity with Computer Systems Validation and instrument qualification, IQ, OQ, PQ
• ASQ CCT (Certified Calibration Technician) or comparable metrology certification
• Experience with measurement uncertainty analysis and NIST traceability documentation
• Prior experience inducting new assets into an existing calibration program