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API Manufacturing Associate I

Facility:  Manufacturing
Location: 

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?
 

This role is for the NIGHT SHIFT, but days during training

 

Position Purpose

Operate API manufacturing equipment to achieve production goals.

 

Accountabilities

  • Work in a safe & environmentally responsible manner
  • Follow instructions listed in GMP documentation & product quality
  • Review 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
  • Load & unload product from trucks, tankers & ISO containers, as required
  • 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
  • Other accountabilities, as assigned

 

Required Qualifications

  • High school graduate or equivalent
  • Ability to read & understand technical documents, (i.e. SOPs, Jls, P&IDs, TROLs, validation protocols, & functional documents)
  • Computer literacy (basic), including ability to navigate all NN systems in a paperless work environment, (i.e. SharePoint, MS Office Suite, Delta V, Syncade, SAP-PM, PS@SAP, Electronic Batch Records)
  • Ability to use material handling equipment in a safe manner, including pallet jacks (manual or powered), hoists, & lifts
  • Mechanical aptitude (basic), including ability to walkdown equipment & follow product flow, ability to use all tools related to tasks, ability to change gaskets & diaphragms up to 2"
  • Cleanroom/Gowning/Sampling: Gowning trained as required per work area, able to perform & log GMP cleaning, able to collect & process samples within LIMS/MES
  • Follow established EHS procedures. Permit Vision Level 1 trained. Demonstrated ability to execute simple & complex Lock Out/Tag Out (LOTO). Trained to work with hazards (waste, chemicals, electrical classifications). Trained & well versed on spill response
  • Demonstrate ability to troubleshoot, identify problems, & propose solutions
  • Training: Track record of sharing knowledge on systems & processes. lsoTrain consistently maintained & up to date
  • cLEAN & Process Improvements: Facilitate an A3 & present findings. Actively participate in board meetings, including being a KPI champion. cLEAN 1 Star trained. Suggest & support implementation of minor improvements
  • Compliant with Corporate/Local SOPs, Regulations & ISO standards
  • Follow cGMP manufacturing practices
  • Fermentation
    • Trained & operationally competent in one (1) fermentation process area & stock solutions & solvents
    • Trained & competent in basic tasks
  • Recovery
    • Trained & operationally competent on stock solutions & solvents and one (1) other recovery process area
    • Trained & competent on basic tasks
  • Purification
    • Trained & operationally competent on two (2) initial purification or final purification areas
    • Trained & competent on basic tasks

 

Desired Qualifications

  • AA/AS/AAS degree or higher in Tech, Science, or Engineering
  • BioWork or equivalent industrial, military or vocational training combined with experience
  • Minimum two (2) years in current role

 

Physical & Other Requirements

  • Ability to move equipment and/or supplies weighing up to 50 lbs. within facility
  • Ability to routinely operate & inspect manufacturing equipment using hands
  • Ability to constantly position oneself to transfer materials within manufacturing environment
  • Ability to frequently move about the building to access other personnel & operational areas
  • Ability to move throughout 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
  • Ability to ascend/descend a ladder to service equipment
  • Ability to work atop elevated positions at heights
  • Ability to secure a motorized vehicle license & operate motorized equipment
  • Ability to work around odorous &/or hazardous materials
  • Ability to perform critical job functions in extremely cold work environments
  • Ability to work around mechanical equipment
  • Ability to work hours as needed to support production including on call, some evenings &/or weekends
  • Ability to position oneself within confined spaces for inspection, repair & maintenance of equipment
  • Ability to work in loud noise environments with hearing protection
  • Ability to travel internationally, as requested
  • Ability to attain clean room gowning certification
  • 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

 

Millions rely on us 
At Novo Nordisk, we don’t wait for change. We drive change. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 40,000 employees to change the lives for the better for millions of patients living with diabetes and other chronic diseases. Together, we go further. Together, we’re life changing.

 

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.