Posted to MedZilla on 6/16/2018


Novo Nordisk

US-NC, Process Engineer III Purification- Precipitation Job 482503800A0-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.


Position Purpose:
To support the successful ramp-up of the purification process for DAPI-US. Drive the process in the precipitation work package & ensure system & equipment reliability.


Accountabilities:

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 vendor & automation FATs.

Participation in equipment qualification & validation activities.

Creation of standard operating procedures (SOPs).

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.


Education:

•BA/BS (pharmacology, engineering, biology) or related field. MANDATORY

•MA/MS in relevant discipline preferred.


Experience: PREFERRED

Minimum of 8 years of experience from operating In a cGMP regulated environment.


Technical/Process/Functional Knowledge: MANDATORY

•Specialist in purification/downstream processes, specifically precipitation & centrifugation.

•Experience with design of requirements documents. Knowledge about requirements/expectations from authorities e.g. FDA.

•Experience with Process Control Systems.


Organization/Planning: PREFERRED
•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.

  • Must be able to be on your feet for up to a 12 hour shift.

  • Constantly positions self to transfer materials within manufacturing environment. Frequently moves about the building to access other personnel & operational areas.

  • Corrected Vision to 20/30 and/or ability to pass vision screening assessment necessary to procurement motorized vehicle license.

  • Occasionally ascends/descends a ladder to service equipment. Works atop elevated positions at heights.

  • Occasionally required to secure a motorized vehicle license & operate a motorized vehicle.

  • Occasionally works around odorous and/or hazardous materials.

  • Occasionally performs critical job functions in extremely cold work environments.

  • Occasionally positions self within confined spaces for inspection, repair & maintenance of equipment.

  • Ability to work in loud noise environments with hearing protection.

  • Able to work in an open office environment with the possibility of frequent distraction.

  • Able to work the hours necessary to support a 24/7 continuous manufacturing operation.

  • Able to travel domestically & internationally, up to 10% of the time.

    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.

    THE SOURCING PERIOD FOR THIS ROLE WILL END 18 JUNE 2018.



Requisition ID: 57051BR
State/Provinces: Clayton
Job Category: Engineering


Please visit our website at www.novonordisk.com

 
 


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