Job Description
One of our large Biotech Clients is seeking a Metrology Engineer to join their team. This indivdual will maintain calibration and preventive maintenance (PM) schedules to ensure the calibration and maintenance programs remain up-to-date and cGMP compliant. Coordinate calibration, PM, and repair activities with System Owners and third-party service providers to ensure minimum equipment downtimes. Calibrate, maintain, troubleshoot, and repair equipment, as needed. Review calibration/maintenance data, verify logbook entries, and enter data in the calibration maintenance management system (CMMS). Assist with developing, implementing and maintaining the Calibration Program in accordance with industry guidelines. Provide technical and administrative support to the user groups and support staff, which include Metrology, Digital, Automation, Facilities, Maintenance, Engineering, Validation, CSV, and EHS. Partner with departments to understand and support current and forecasted needs for each area.
Required Skills & Experience
* BS degree or equivalent work experience in a science/engineering-related field is required.
* 3+ years' experience in instrument calibration and maintenance functions within the pharmaceutical /biotechnology industry.
* Experience in calibration and/or metrology is required with preferred expertise on bioreactors, liquid handling systems, and analytical instrumentation/systems.
* Experience with 21CFR Part 11 compliant computerized calibration and maintenance management systems (SAP, ProCal, Blue Mountain RAM, etc.) is preferred.
* Strong knowledge and experience with established standards and industry guidelines: FDA, GAMP, ISPE, ISO, ASTM, USP, cGMP, GDP, etc.
* Direct experience with Regulatory Inspections is preferred.
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.