Calibration & Gauge Management Specialist

About the role

We are seeking a Calibration & Gauge Management Specialist to own the full calibration lifecycle for our pharmaceutical manufacturing equipment. The role ensures all gauges and instruments are calibrated, verified, and documented in compliance with ISO and cGMP standards, supporting product quality and regulatory readiness.

Key responsibilities

• Obtain calibration quotes, create purchase requisitions in SAP, and schedule internal and external calibrations.
• Perform internal verifications, coordinate routine gauge maintenance, and assist with troubleshooting and repairs.
• Maintain the gauge management system, including accurate records of maintenance, repairs, and calibration certificates.
• Support Gage R&R studies, CAPA investigations, and continuous improvement initiatives.
• Package, ship, and archive gauges and related documentation both digitally and physically.
• Train employees on proper gauge use and maintenance.
• Participate in customer, regulatory, and internal audits as needed.
• Execute gauge validation and qualification protocols and manage related CAPAs and non‑conformances.

Required profile

• High School Diploma or GED required; minimum 2 years of experience in gauge management, calibration, or a quality‑focused manufacturing role.
• Experience working in a fast‑paced manufacturing environment.
• Solid knowledge of ISO 9001, ISO 13485, ISO 15378, and cGMP requirements.

Required skills

• SAP
• Microsoft Office (Excel, Word, PowerPoint)
• Understanding of ISO 9001, ISO 13485, ISO 15378 standards
• Familiarity with cGMP regulations