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Job Description & How to Apply Below
Job Title:
QA Calibration Specialist / Calibration Engineer
Location:
United States
This position is open exclusively to people who are eligible to work in USA.
Job Summary We are seeking an experienced QA Calibration Specialist / Calibration Engineer to support calibration, metrology, and validation activities in a GMP-regulated pharmaceutical/biotech setting.
Responsibilities Perform calibration and metrology activities for manufacturing, utilities, and QC laboratory equipment.
Support commissioning, qualification, and validation activities (IQ/OQ/PQ).
Review SOPs, calibration procedures, P&IDs, instrumentation drawings, and vendor documentation.
Manage CMMS systems such as Blue Mountain.
Investigate Out-of-Tolerance (OOT) events and support CAPA implementation.
Ensure compliance with FDA/GMP regulations and NIST traceability standards.
Coordinate with Engineering, Validation, QA, Facilities, and Manufacturing teams.
Required Skills & Experience 5+ years of calibration/metrology experience in pharmaceutical, biotech, or medical device industries.
Robust knowledge of GMP/GLP environments, calibration standards, CAPA, OOT investigations, and IQ/OQ/PQ documentation.
Experience calibrating pressure, temperature, flow, humidity, conductivity, HVAC/BMS, autoclaves, lyophilizers, and analytical instruments.
Ability to read and interpret P&IDs and instrumentation diagrams.
Experience with Blue Mountain or similar CMMS/calibration software preferred.
Qualifications Bachelor’s degree in Engineering, Life Sciences, Metrology, or related field.
Solid technical documentation and communication skills.
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