US-NC, Process Engineer III - Purification HPLC Job 432728300A3-MZ
|Requisition ID 50449BR|
Title Process Engineer III - Purification HPLC
Job Category Engineering
Job Description 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.
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. Once established, drive the process in the purification department & ensure system & equipment reliability.
* 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 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 required; MA/MS preferred.
* 8-15+ years of experience operating in a GMP regulated environment.
Technical/Process/Functional Knowledge: MANDATORY
* Specialist in purification/downstream processes, specifically chromatography.
* 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:
* 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 to process equipment & areas.
* Ability to work hours necessary to support production & maintenance activities.
* Ability to travel locally & internationally as necessary.
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.
Department DAPI US Process Support Purification
Position Location US - Clayton, NC
State/Provinces US - NC
Job/Position Country US
At Novo Nordisk, we know that driving change on a global level and improving treatment outcomes for people with diabetes and other chronic diseases begins here at home. That's why we make an unmatched commitment to our employees, our families and our communities. That means outstanding rewards, industry-leading training programs, and an environment that supports you to achieve your goals at every level. It's all part of the Novo Nordisk Way. It includes our Vision and our commitment to the Triple Bottom Line principle – helping us find the right balance between compassion and competitiveness
With a career at Novo Nordisk, you’ll feel a difference right from the start. It’s a sense of inspiration and mobility that comes from a shared belief in driving positive change for people, families, and communities everywhere. Congratulations on taking your first step!
Novo Nordisk is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.
Please visit our website at www.novonordisk.com