US-NC, GMP Partner - Automation API Quality Job 459837900A3-MZ
|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.
Design & develop quality & compliance set-up for the Automation process during the project. Ensure good execution & monitoring according to the FDA Good Manufacturing Practices (GMP) requirements.
•BA/BS in Life Sciences, Engineering, or related field or equivalent combination of education & experience.
•10+ work experience in pharmaceutical manufacturing.
•8+ years of GMP, QA &/or related experience in the pharmaceutical or medical device industry with progressively increasing responsibility.
•Demonstrated expertise in regulations & quality systems (e.g. NC/CAPA, Change Control, Audits, Validation, etc.).
•Familiarity with processes & quality systems within assigned process track.
Technical/Process/Functional Knowledge: MANDATORY
•Experience with Manufacturing Execution Systems, Process Control Systems, Historian, Building Management Systems, PLC & SCADA systems.
•Solid experience in S88, S95 batch model.
•Knowledge within API processes.
•Extended knowledge in GAMP.
•Excellent written & verbal communication skills.
•Basic computer skills in MS Office, MS Project, PowerPoint, etc.
Demonstrated excellence in time management, organizational, & project management skills. Ability to work in a high performance team environment.
Physical & Other Requirements:
•Ability to work in & around an active construction site during project phase.
•Ability to move throughout the facility in the performance of duties in proximity of process equipment & areas.
•Ability to work hours necessary & according to process needs.
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 Opportunity Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity.
If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
Requisition ID: 54397BR
Job Category: Quality
Please visit our website at www.novonordisk.com