US-NC, Process Engineer II - Purification, HPLC Job 462447900A2-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.
To support the successful ramp-up of the purification process for DAPI-US. Support the initial definition of user requirements for the purification area including High Pressure Liquid Chromatography (HPLC). Once established drive the process in the purification department & ensure system & equipment reliability.
Support validation within area.
Support 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 design work shops with engineering suppliers.
Input, review & approval of Process Module Diagrams, & Process Flow Diagrams.
Input, review & approval of Process Scheduling, Capacity Calculations & Equipment Sizing.
Input, review & approval of process Lay-Out diagrams.
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. nmmm
BA/ BS (pharmacology, engineering, biology) or related field MANDATORY
5-8+ years of experience from operating In a GMP regulated environment
Technical/Process/Functional Knowledge: MANDATORY
•Specialist in purification/downstream processes, e.g. chromatography, filtration & related solvent systems.
•Experience with design of requirements documents.
•Knowledge about requirements/expectations from authorities e.g. FDA.
•Experience with Process Control Systems.
Proven ability to establish & maintain networks & facilitate processes that encourage cross organizational knowledge sharing
Physical & Other Requirements:
•Requires 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: 54738BR
Job Category: Engineering
Please visit our website at www.novonordisk.com