Calibration Engineer

Key Responsibilities Perform calibration and metrology activities for GMP manufacturing, utilities, and QC lab equipment. Support commissioning, qualification, and validation activities (IQ/OQ/PQ). Review calibration procedures, SOPs, P&IDs, instrumentation drawings, and vendor documents. Manage CMMS systems such as Blue Mountain. Investigate Out-of-Tolerance (OOT) events and implement CAPA actions. Ensure NIST traceability and compliance with FDA/GMP regulations. Coordinate with Engineering, Validation, QA, Facilities, and Manufacturing teams. Support calibration of: Pressure, temperature, flow, humidity, conductivity instruments HVAC/BMS systems Autoclaves, lyophilizers, CIP/SIP systems HPLC/GC analytical instruments Cleanroom and utilities equipment Required Skills GMP/GLP calibration and metrology experience Experience with pharmaceutical or biotech environments Strong knowledge of: Calibration standards CMMS systems OOT investigations CAPA IQ/OQ/PQ documentation Ability to read P&IDs and instrumentation diagrams Good documentation and technical writing skills Qualifications Bachelor's degree in engineering, Life Sciences, Metrology, or related field 2–5+ years of calibration/metrology experience in pharma/biotech/medical devices Experience with Blue Mountain or similar calibration software preferred