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Process Engineer II - Initial Purification

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

Support the ongoing development of the purification process for DAPI-US. Support the ongoing definition of user requirements for the purification area. Drive the processes in the purification department & ensure system & equipment reliability.

 

Accountabilities

  • Support validation within area
  • Drive equipment qualification & optimization
  • Support quality of equipment & processes in DAPI-US
  • Support process monitoring activities for key process parameters
  • Ensure identification of & collaboration regarding interfaces to other processes & support systems
  • Input & review to Process FMECA’s for purification of project products
  • Support Purification project team in maintaining schedule adherence
  • Ensure coordination & collaboration between DAPI-US & other site stakeholders
  • Gather & ensure knowledge transfer to project from similar production sites in Novo Nordisk

 

Required Qualifications

  • BA/BS (pharmacology, engineering, biology) or equivalent combination of education & relevant experience in a GMP regulated environment
  • Minimum of five (5) years of experience operating in a Good Manufacturing Practice (GMP) regulated environment
  • Experience in purification/downstream processes, e.g. chromatography, centrifugation, solvent prep, filtration
  • Knowledge about requirements/expectations from authorities e.g. Food & Drug Administration (FDA)
  • Experience with Process Control Systems

 

Desired Qualifications

Proven ability to establish & maintain networks & facilitate processes that encourage cross organizational knowledge sharing.

 

Physical & Other Requirements

  • Occasionally moves equipment and/or supplies weighing up to 50 pounds within the facility
  • Routinely operates & inspects manufacturing equipment using hands
  • Ability to be on feet for up to a 12-hour shift
  • Constantly positions oneself to transfer materials within manufacturing environment. Frequently moves about building(s) to access other personnel & operational areas
  • Corrected vision to 20/30 &/or ability to pass vision screening assessment necessary to procure motorized vehicle license
  • Occasionally ascends/descends a ladder to access service equipment. Works atop elevated positions at heights
  • Occasionally required to secure a motorized vehicle license & operate a motorized vehicle
  • Occasionally works around odorous &/or hazardous materials
  • Occasionally performs critical job functions in extremely cold work environments
  • Occasionally positions oneself within confined spaces for inspection, repair & maintenance of equipment
  • Ability to work in loud noise environments with hearing protection
  • Ability to travel locally or internationally, as needed
  • Ability to work in an open office environment with the possibility of frequent distraction
  • Ability to work the hours necessary to support a 24/7 continuous manufacturing operation

 

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.

Process Engineer II - Initial Purification

Clayton, NC
Full Time

Published on 11/19/2020