Process Engineer I - Fermentation Job:
Novo Nordisk

Novo Nordisk
Clayton North Carolina

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:

Ensure successful qualification & execution of the project phases for the Fermentation process, evolving into a process subject matter expert for the Fermentation area.

Main tasks include:

  • Support team in ensuring installed design adheres to process requirements.
  • Coordinate & execute process validation activities
  • Provide technical support of the operating facility to meet business goals
  • Coach & mentor less experienced members of the process engineering team.


  • Overall validation responsible within area.
  • Execute & coordinate all qualification activities included in the project (SAT, IQ, OQ, PQ)
  • Lead / provide technical support to investigation & resolution of VNC’s & NC’s.
  • Support development & implementation of change requests during commissioning & operation.
  • Verify process equipment & facilities satisfy design requirements. Ensure designs comply with current pharmaceutical standards applicable for the project such as ASME BPE, GAMP, cGMP, ISPE guidelines.
  • Gathering & ensure knowledge transfer to project from DK sponsor site. Support or serve as Process Responsible in Process Groups.
  • Support work packages in maintaining schedule & project milestone adherence.
  • Ensure coordination & collaboration between project & other site stakeholders.
  • Ensure design adheres with process FMECA's & resolve misalignments where observed.
  • Develop knowledge of risk assessment documents such as requirements risk assessments (RRA's).
  • Support update, development & design adherence to requirement specification documents.
  • Participation in review & update of QRM risk assessments such as closed-system, cross-contamination, contamination & facility flows.
  • Apply Fermentation knowledge to the review & update of design documentation (process flow diagrams, P&IDs, etc.).
  • Provide design basis information for accurate process scheduling & capacity calculations.

Requires Qualifications:

  • BA/BS in chemical engineering, biological / biomedical engineering, or other pharmaceutical related field
  • Minimum of two (2) years of engineering experience in operations, process design/troubleshooting/improvement.

Desired/Preferred Qualifications:

  • Six Sigma Green Belt certification or cLEAN® 2-star desired.
  • Experience of working with cGMPs & their applications.
  • Demonstrated experience in chemical/biological manufacturing processes.
  • Knowledgeable in the following systems: Instrument & Electrical, Mechanical, Control/SCADA/PLCs, Process Improvement Methods, Root Cause Analysis (RCA), Maintenance & Reliability.
  • Ability to independently apply engineering techniques & analysis within the discipline.
  • Strong project management skills.
  • Excellent oral & written communication skills.
  • Proven expertise in planning/organization/execution of maintenance activities & following up on results.
  • Creating and/or revising the work plan for complex problems being resolved by cross functional teams

Physical 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 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 and/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 and/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.
  • Able to work in loud noise environments with hearing protection.
  • Able to travel internationally, up to 10% of the time.
  • 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.

The sourcing period for this role will end 22 May 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: 59853BR
State/Provinces: Clayton
Job Category: Engineering

Basic Qualifications