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Posted: Saturday, December 16, 2017 12:07 AM

Requisition ID 52737BR
Title Metrology Area Specialist API
Job Category Manufacturing
Job Description Your Groundbreaking Journey
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 and maintain instrumentation specifications, calibration standards and associated processes in accordance with cGMP, site/corporate procedures, policies, and business needs to support the DAPI:US project.
Accountabilities:
-Work in a safe and 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 and standards for instrumentation.
-Create and maintain equipment master files for all calibrated instruments.
-Coordinate all required method transfers.
-Coordinate all calibration activities and vendor supported calibration activities.
-Establish and 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 and /or calibration activities.
-Experience investigating OOT results.
Technical/Process/Functional Knowledge: PREFERRED
-Demonstrated expertise in measurement instrumentation theory and method development.
-Demonstrated expertise in managing calibration activities in pharmaceutical instrumentation using calibration software.
-Experience using SAP PM and QM. (DESIRED)
-Working knowledge of GMPs, corporate, and site level requirements and procedures.
-Ability to read/review design drawings (CAD) with a basic understanding of P and ID, HVAC and Electrical systems.
-Understanding of technical documents such as URS, SAT, FAT, Validation Protocols.
-Demonstrated ability to write technical documents and reports.
-Demonstrated ability to present technical information to others. (DESIRED)
Organization/Planning: PREFERRED
Demonstrated ability to manage multiple tasks and responsibilities with competing priorities.
Physical and Other Requirements:
-Ability to lift up to 30 lbs. with assistance.
-Ability to move throughout the facility in the performance of duties in proximity to process equipment and areas.
-Ability to work flexible hours as necessary to meet customer and production needs.
-Ability to work in and around an active construction site during project phase.
-Domestic and International travel as required.
At this time, Novo Nordisk is not currently hiring individuals for this position who now or in the future would require sponsorship for employment visa status.
Novo Nordisk is an Equal O

Source: https://www.tiptopjob.com/jobs/75981836_job.asp?source=backpage


• Location: clayton, Raleigh / Durham

• Post ID: 55984977 raleigh
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