API Manufacturing Associate I

Facility:  Manufacturing
Location: 

Clayton, NC, US

About the Department

At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. For nearly 100 years, we have led the way in diabetes care. As a result, our employees embark on life-changing careers with opportunities for mobility and growth within a global organization. At Novo Nordisk, you will work with the best manufacturing professionals in the industry.

 

Our new Active Pharmaceutical Ingredients (API) facility houses the Fermentation, Recovery and Purification in the production of ingredients for Novo Nordisk’s innovative oral products. Are you ready to help make what matters? Then, we are ready for you!

 

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
  • Computer literacy including, but not limited to, ability to operate computer driven manufacturing/production equipment & efficient use of Microsoft Office suite programs
  • 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
  • Ensure compliance with corporate/local SOPs, regulations & ISO standards
  • General knowledge in cGMP manufacturing & production processes associated with pharmaceutical companies

 

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 of manufacturing experience in FDA regulated environment
  • 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
  • Experience following SOPs to perform tasks & raising issues if errors are found
  • Experience following established safety guidelines when performing tasks
  • Basic knowledge of biology/chemistry
  • Mechanical aptitude, ability to follow use tools to perform tasks, basic troubleshooting of mechanical components & systems
  • Experience working with work permits/Lock Out Tag Out systems

 

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

 

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

 

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. 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.

 

Novo Nordisk requires all new hires to be fully vaccinated against COVID-19 prior to the first date of employment. As required by applicable law, Novo Nordisk will consider requests for reasonable accommodation.

 

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.