Specialist, Metrology

The Specialist, Metrology ensures successful implementation of metrology strategies as directed by the Manager and serves as the SME for Metrology & Calibration. Serves as the site representative for the CMC Product Supply global metrology process group and others as assigned. Acts as point of contact between line of business and Metrology Area Specialists. Ensures calibration specifications and methods are in accordance with cGMP and site/corporate procedures and business needs. Ensures close collaboration with NN Product Supply Quality.

Reports to Manager, Facilities & Utilities.

Essential Functions:
- Works safely and in an environmentally responsible way
- Drive creation and approval of calibration specifications and methods for the site
- Serve as SME to support equipment/system owners (cal specs, problem solving, instrument selection, deviations, etc.)
- Coach technicians and site staff in training, problem solving, and Metrology improvement
- SME for deviations related to Metrology/Calibration process
- Identify and drive improvements in calibration methods, standards, reliability, and specifications
- Drive alignment/standardization for calibration specifications, methods, and calibration record keeping
- Site responsible/lead for Metrology initiatives
- Lead/participate in planning and execution of complex Metrology activities (including optimization/investment projects)
- Lead initiative to create internal Metrology Lab, including Calibration annual budgets
- Metrology SME for audits/inspections (preparedness and participation)

Qualifications:
- Bachelor’s degree + 2+ years experience required (or Master’s + 0+ years)
- Degree in related engineering/science or equivalent combination of education and metrology experience
- Pharmaceutical calibrations/metrology or other highly regulated industry experience (preferred)
- Planning maintenance and/or calibration activities (required)
- Investigating GMP calibration or instrument failures (required)
- Preparing technical instructions/procedures (required)
- Expertise in measurement instrumentation theory and method development (required)
- Expertise in calibrating pharmaceutical/regulated instrumentation (required)
- Working knowledge of cGMPs and corporate/site requirements (required)
- Write technical documents/reports (preferred); present technical information (required)
- Word/Excel (preferred); measurement uncertainty handling/accounting (preferred)
- Manage competing priorities and systematic problem-solving (preferred)