Metrology Area Specialist API Job - Clayton, NC

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  • Published date: December 14, 2017
    • Clayton, North Carolina, United States

At Novo Nordisk, we want to make a difference. For more than 90 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help and improve the quality of life for millions of people around the world.

To help meet the growing demand for our diabetes treatment, Novo Nordisk expects to double production of diabetes drugs over the next decade. Novo Nordisk is currently building a new diabetes API plant in Clayton, NC next to our existing facility that employs 800 people. The new plant will initially employ 700 employees to produce the active ingredients for a new diabetes oral treatment and a range of other diabetes drugs.

Novo Nordisk is currently seeking top talent for this green field project and eventual operations. This once in a life-time career opportunity is ideal for manufacturing professionals who not only understand the operational complexities of manufacturing but also have the desire and drive to help us design and build. Here you will work with the best manufacturing professionals in the industry, while learning and taking part in the plant design.

Position Purpose:
This position will develop, manage & maintain instrumentation specifications, calibration standards & associated processes in accordance with cGMP, site/corporate procedures, policies, & business needs to support the DAPI-US project.

Accountabilities:

•Work in a safe & environmentally responsible way.
•Coordinate the development of all SAP Master Data for instrumentation.
•Coordinate the development of all calibrations in SAP QM.
•Coordinate the development of all calibration methods & standards for instrumentation.
•Create & maintain equipment master files for all calibrated instruments.
•Coordinate all required method transfers.
•Coordinate all calibration activities & vendor supported calibration activities.
•Establish & maintain alignment with the global process group.
•Other accountabilities as assigned.

Education: PREFERRED
BA/BS degree in related engineering or science discipline or equivalent (experience + education).

Experience: PREFERRED
•7+ years of experience in pharmaceutical manufacturing.
•5+ years of experience in metrology in pharmaceutical manufacturing.
•Experience in planning maintenance &/or calibration activities.
•Experience investigating OOT results.

Technical/Process/Functional Knowledge: PREFERRED
•Demonstrated expertise in measurement instrumentation theory & method development.
•Demonstrated expertise in managing calibration activities in pharmaceutical instrumentation using calibration software.
•Experience using SAP PM & QM. (DESIRED)
•Working knowledge of GMPs, corporate, & site level requirements & procedures.
•Ability to read/review design drawings (CAD) with a basic understanding of P&ID, HVAC & Electrical systems.
•Understanding of technical documents such as URS, SAT, FAT, Validation Protocols.
•Demonstrated ability to write technical documents & reports.
•Demonstrated ability to present technical information to others. (DESIRED)...cont.

Learn more and apply online at http://www.hirelifescience.com/metrology-area-specialist-api-job/clayton-nc-11111-765488/?p=p&submission=2

Matthew Masterson
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