US-NC, Process Engineer III Purification- Precipitation Job 482503800A0-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.
Overall validation responsible within area.
Ensure quality of equipment & processes in DAPI-US.
Ensure identification of & collaboration regarding interfaces to other processes & support systems in the project.
Creation of risk assessment documents, such as Requirement Risk Assessments (RRA’s).
Creation & participation in QRM risk assessments, such as Closed-Process, Contamination & Facilities flows.
Input & review to Process FMECA’s for purification of project products.
Participation in vendor & automation FATs.
Participation in equipment qualification & validation activities.
Creation of standard operating procedures (SOPs).
Support Purification project team in maintaining schedule adherence.
Ensure coordination & collaboration between project & other site stakeholders.
Gather & ensure knowledge transfer to project from similar production sites in Novo Nordisk.
•BA/BS (pharmacology, engineering, biology) or related field. MANDATORY
•MA/MS in relevant discipline preferred.
•Minimum of 8 years of experience from operating In a cGMP regulated environment.
•Specialist in purification/downstream processes, specifically precipitation & centrifugation.
•Experience with design of requirements documents. Knowledge about requirements/expectations from authorities e.g. FDA.
•Experience with Process Control Systems.
Requisition ID: 57051BR
Job Category: Engineering
Please visit our website at www.novonordisk.com