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Process Engineer II - Purification HPLC at Novo Nordisk in Clayton, North Carolina

Posted in Other 30+ days ago.

Type: Full Time

Job Description:

About the Department

At Novo Nordisk, we want to make a difference. For more than 95 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 improve the quality of life for millions of people around the world. Help us bring quality to life. Working at our Diabetes Active Pharmaceutical Ingredient (DAPI) manufacturing facility you will help meet the growing demand for our treatments. Novo Nordisk expects to double production of diabetes and obesity drugs over the next decade and are currently building a new 825,000 sq. ft diabetes Active Pharmaceutical Ingredient (API) plant in Clayton, NC next to our existing \\"fill and finish\\" manufacturing facility. Our new $2 billion API facility is expected to be operational in 2020, with 700 full-time employees responsible for the fermentation, recovery and purification of insulin and GLP1 ingredients. This once in a life-time career opportunity is ideal for pharmaceutical manufacturing professionals who not only understand the operational complexities of manufacturing but also have the desire and drive to help us build, validate, and run our processes. Here, you will work with the best manufacturing professionals in the industry. Are you ready to make a difference?

Position Purpose

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

Required Qualifications

* BA/ BS (pharmacology, engineering, biology) or related field

* 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. Food & Drug Administration (FDA)

* Experience with Process Control Systems

Desired Qualifications

* 5-8+ years of experience from operating In a Good Manufacturing Practice (GMP) regulated environment

* 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.