API Manufacturing Associate I

Facility:  Manufacturing

Clayton, NC, US

About the Department                                                                                                                                             

At Novo Nordisk, we want to make a difference. For nearly 100 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. 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 products over the next decade; we have recently completed construction of a 825,000 sq. ft diabetes Active Pharmaceutical Ingredient (API) plant in Clayton, NC. Our new API facility houses the fermentation, recovery and purification of GLP1 ingredients for Novo Nordisk’s innovative oral products. Here, you will work with the best manufacturing professionals in the industry. Are you ready for a life-changing career?

We are recruiting for multiple openings and you must be open to day shift or night shift.  


Hiring for Fermentation, Recovery and Purification


Position Purpose

Operate API manufacturing equipment to achieve production goals.



  • Work in a safe & environmentally responsible manner
  • Follow instructions listed in Good Manufacturing Practice (GMP) documentation & product quality
  • Review Standard Operating Procedures (SOP’s) & other documents, as required
  • Real time review of electronic batch records ensuring compliance to Standard Operating Procedures (SOPs) & current Good Manufacturing Practices (cGMP) standards
  • Manage individual training plan
  • Participate in qualification & validation activities as required
  • Setup, operate, monitor, & control highly automated processes & systems
  • Execute production schedule to achieve production goals
  • Utilize investigation skills during troubleshooting & assist during equipment maintenance, including restoration of lost function, predictive & preventative maintenance
  • Maintain clean room areas & perform environmental monitoring, as required
  • Record/review production data in BPR, log books & other associated forms & review all data for entire team.  Ensure all errors are addressed & corrected real time ensuring compliance with cGMPs
  • Other accountabilities, as assigned


Required Qualifications

  • High school graduate or equivalent
  • Computer literacy including, but not limited to the ability to operate computer driven manufacturing/production equipment & efficient use of Microsoft Office suite programs


Desired Qualifications

  • BA/BS degree or higher in related field and/or a minimum of 2 years of experience in an FDA regulated manufacturing industry
  • BioWork or equivalent
  • Experience with Fermentation, Centrifuges, Chromatography or similar equipment preferred
  • Experience demonstrating a systematic approach to problem solving & troubleshooting based on data & facts. Actively participated in & driven event response activities. Documented problems & worked on ensuring rapid resolution & preventing recurrence
  • Basic knowledge of biology/chemistry
  • Ability to read & understand complicated product documentation & standard operating procedures with attention to detail
  • Ability to perform basic material handling tasks & safely & effectively use material handling equipment
  • Experience with electronic batch records, automated process equipment, and/or DeltaV or Syncade
  • Proven ability to check results & revise work tasks to meet daily plan
  • Direct interaction in supporting stakeholders & potentially assisting with coordination of planned & corrective maintenance activities to ensure successful process turnaround/performance


Physical & Other Requirements

  • Able to move equipment and/or supplies weighing up to 50 pounds within the facility
  • Able to routinely operate & inspect manufacturing equipment using hands
  • Able to remain in a stationary position up to 100% of the time
  • Able to constantly position oneself to transfer materials within manufacturing environment
  • Able to frequently move about the building to access other personnel & operational areas
  • Able to move throughout the facility to interact with other employees in the normal office & manufacturing environment
  • Corrected vision to 20/30 and/or ability to pass vision screening assessment necessary to procure motorized vehicle license
  • Able to ascend/descend a ladder to service equipment
  • Able to work atop elevated positions at heights
  • Able to secure a motorized vehicle license & operate motorized equipment
  • Able to work around odorous and/or hazardous materials
  • Able to perform critical job functions in extremely cold work environments
  • Able to work around mechanical equipment
  • Able to work hours as needed to support production including on call, some evenings and/or weekends
  • Able to position oneself within confined spaces for inspection, repair & maintenance of equipment
  • Able to work in loud noise environments with hearing protection
  • Able to work in & around an active construction site during project phase
  • Able to travel internationally
  • Able to attain clean room gowning certification
  • Ability to work hours necessary to support production, including ability to stand on feet up to 12 hours or longer, day or night


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.  Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.


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.