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. We are currently seeking top talent for our two pharmaceutical manufacturing facilities in Clayton, NC.
Working at our Diabetes Active Pharmaceutical Ingredient (DAPI) manufacturing facility
Your Groundbreaking Journey
To help meet the growing demand for our treatments, Novo Nordisk expects to double production of diabetes and obesity drugs over the next decade. We 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 design, build and validate our processes. Here, you will work with the best manufacturing professionals in the industry, while learning and taking part in the plant design.
Position Purpose: To support the successful ramp-up of acylation/ligation processes in the purification facility. To support the initial definition of user requirements for the purification area. Once established, support 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.
BA/BS (pharmacology, engineering, biology) or related field
3-5+ years of experience operating in a GMP regulated environment.
Specialist in purification/downstream processes, e.g. chromatography, filtration, centrifugation & 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.
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.
The sourcing period for this role will end 30 September 2019
Life-Changing Careers with Novo Nordisk
With a local presence for more than 25 years, Novo Nordisk is one of the largest employers in Johnston County, with over 1,200 highly-skilled and dedicated employees working in Clayton and a diverse, global workforce of more than 40,000.
We aspire to operate in a socially responsible way, and we are committed to offering a healthy and engaging workplace. Our Clayton manufacturing facilities have been honored as a FORTUNE 100 Best Places to Work For 10 years in a row. Other recent employer honors include the ISPE Company of the Year, the Triangle Business Journal Healthiest Employers in the Triangle and the NC Department of Labor 2 Million Hour Safety Award. Approximately 19% of our Clayton employees are veterans, and we offer year-round opportunities to give back to the community. If you’re looking for a life-changing career with real impact, join our team and help us defeat diabetes, obesity and other chronic diseases.
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: 60383BR
Job Category: Engineering