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Job Description

Maintain and manage calibration and preventive maintenance (PM) schedules to ensure programs remain current and cGMP compliant. Coordinate calibration, PM, and repair activities with System Owners and external vendors to minimize equipment downtime. Perform calibration, maintenance, troubleshooting, and equipment repairs as needed. Review calibration/maintenance data, verify logbook entries, and enter information into the CMMS. Support the development and upkeep of the Calibration Program in alignment with industry guidelines. Provide technical and administrative support to partner groups including Metrology, Digital, Automation, Facilities, Maintenance, Engineering, Validation, CSV, and EHS. Collaborate with departments to understand and meet current and future equipment needs.

Responsibilities

70% — Calibration & Maintenance Operations

Manage calibration and PM schedules to ensure timely completion. Perform equipment calibration, maintenance, troubleshooting, and repairs. Coordinate instrument pick-up/drop-off for offsite service. Apply measurement science and engineering principles to develop and maintain calibration systems and procedures. Partner with user groups to optimize instrument performance.

10% — Documentation Management

Maintain master instrument records, history files, and CMMS documentation. Ensure all Metrology documents remain audit-ready.

5% — OOT Support

Assist in creating Out-Of-Tolerance reports, deviations, and impact assessments.

5% — Vendor & Parts Management

Research service options, reduce vendor reliance, and maintain parts inventory.

5% — Training

Maintain up-to-date training and manage training records for third-party service providers.

5% — Additional Duties

Perform other tasks as assigned by management.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to [email protected] learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

Skills and Requirements

BS in a science/engineering field or equivalent experience.

3+ years in instrument calibration/maintenance within pharma/biotech. Calibration/metrology experience required; bioreactors, liquid handlers, and analytical

Experience with 21 CFR Part 11–compliant CMMS systems (SAP, ProCal, Blue Mountain, etc.)

Strong knowledge of FDA, GAMP, ISPE, ISO, ASTM, USP, cGMP, GDP standards.

Regulatory inspection experience