Specialist, Metrology

Novo Nordisk•Boulder, CO

7d•Onsite

About The Position

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

Requirements

Bachelor's degree from an accredited university and 2+ years of experience required.
Equivalent experience requirements for advanced degrees would be a Master's degree and 0+ years of experience
Degree in related engineering or science discipline or equivalent combination of education & metrology experience required
Experience in planning maintenance &/or calibration activities required
Experience investigating GMP calibration or instrument failures required
Experience in preparing technical instructions/procedures required
Demonstrated expertise in measurement instrumentation theory & method development required
Demonstrated expertise in calibrating pharmaceutical or other highly regulated instrumentation required
Working knowledge of cGMPs, corporate & site level requirements & procedures required
Demonstrated ability to present technical information to others required
Working knowledge of Word & Excel software applications preferred
Working knowledge of handling & accounting for measurement uncertainty preferred
Demonstrated ability to manage multiple tasks & responsibilities with competing priorities preferred
Demonstrated systematic approach to problem solving & troubleshooting preferred

Nice To Haves

Experience in pharmaceutical calibrations/metrology or other highly regulated industry preferred
Demonstrated ability to write technical documents, instructions & reports preferred

Responsibilities

Works in a safe & environmentally responsible way
Drive the creation & approval of calibration specifications & methods for the site
Acts as SME to support equipment & system owners in all aspects related to instrumentation (cal specs, problem solving, instrument selection, deviations, etc.).
Coach technicians and site staff in training, problem solving & improvement of Metrology
SME for deviations related to Metrology/Calibration process
Identifies & drives improvements in calibration methods, standards, reliability & specifications to fulfill customer needs & to align with overall site strategy aligning with corporate standards
Drives alignment & standardization for calibration specifications, methods & Blue Mountain Ram calibration record keeping
Site responsible & lead for Metrology initiatives
Lead & participate in planning & execution of larger &/or complex activities related to Metrology, including optimization & investment projects
Serves as SME by leading initiative to create internal Metrology Lab, including creation of Calibration annual Budgets
Metrology SME for audit & inspection. Responsible for preparedness & participation
Other accountabilities, as assigned