API Manufacturing Associate I (Night Shift)

Novo Nordisk AS

Clayton, NC

JOB DETAILS
SKILLS
Active Pharmaceutical Ingredient (API), Application Programming Interface (API), Biology, Biotech and Pharmaceutical, Chemistry, Chronic Disease, Cleanroom, Computer Skills, Corporate Compliance, Current Good Manufacturing Practice (cGMP), Dental Insurance, Detail Oriented, Diabetes, Disability Insurance, Disease, Documentation Standards, Drug Manufacturing, Environmental Monitoring, Equipment Maintenance/Repair, FDA (Food and Drug Administration), Fermentation, GMP (Good Manufacturing Practices), Hazardous Materials/Substances, Health Insurance, Healthcare, High School Diploma, Housekeeping/Cleaning, ISO (International Organization for Standardization), Identify Issues, Life Insurance, Loading/Unloading, Maintain Compliance, Manufacturing, Manufacturing Equipment, Manufacturing/Industrial Processes, Mentoring, Microsoft Office, Pallet Jack, Preventative Maintenance, Problem Solving Skills, Product Documentation, Product Marketing, Production Schedule, Regulations, Regulatory Compliance, Safety/Work Safety, Standard Operating Procedures (SOP), Tuition Fees, Vision Plan
LOCATION
Clayton, NC
POSTED
30+ days ago

About the Department

At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world.

In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our newer Active Pharmaceutical Ingredients (API) facility in Clayton, NC sits on 825,000 square-feet of state-of-the-art equipment, and houses the Fermentation, Recovery and Purification in the production of ingredients for Novo Nordisk's innovative oral products. At API, you'll join a global network of manufacturing professionals who are passionate about what they do.

What we offer you:

  • Leading pay and annual performance bonus for all positions
  • All employees enjoy generous paid time off including 14 paid holidays
  • Health Insurance, Dental Insurance, Vision Insurance - effective day one
  • Guaranteed 8% 401K contribution plus individual company match option
  • Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
  • Free access to Novo Nordisk-marketed pharmaceutical products
  • Tuition Assistance
  • Life & Disability Insurance
  • Employee Referral Awards

At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.

The Position

Operate API manufacturing equipment to achieve production goals.

Relationships

Reports to Shift Manager, Operations - API.

Essential Functions

  • 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

Physical Requirements

Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Routinely operates & inspects manufacturing equipment using hands. Strap & unstrap pallets using hands. Must be able to be on your feet for up to a 12-hour shift. May require corrected vision to 20/20 or 20/25 based on role. May require color vision based on role. Occasionally ascends/descends a ladder. May be required to work at elevated heights. Occasionally works around odorous &/or hazardous materials. May be required to wear latex gloves. May perform critical job functions in extremely cold work environments depending on site. May position oneself within confined spaces for inspection if required of the role. Ability to work in loud noise environments with hearing protection. May be required to secure a motorized vehicle license & operate a motorized vehicle based on the role.

Qualifications

  • High school graduate or equivalent required
  • Associates Degree or higher in Tech, Science, or Engineering preferred
  • BioWork or equivalent industrial, military or vocational training combined with experience preferred
  • Minimum two (2) years of manufacturing experience in FDA regulated environment 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 preferred
  • Experience following SOPs to perform tasks & raising issues if errors are found preferred
  • Experience following established safety guidelines when performing tasks preferred
  • Computer literacy including, but not limited to, ability to operate computer driven manufacturing/production equipment & efficient use of Microsoft Office suite programs required
  • Ability to read & understand complicated product documentation & standard operating procedures with attention to detail required
  • Ability to perform basic material handling tasks, safely & effectively use material handling equipment required
  • Ensure compliance with corporate/local SOPs, regulations & ISO standards required
  • General knowledge in cGMP manufacturing & production processes associated with pharmaceutical companies required
  • Basic knowledge of biology/chemistry preferred
  • Mechanical aptitude, ability to follow use tools to perform tasks, basic troubleshooting of mechanical components & systems preferred
  • Experience working with work permits/Lock Out Tag Out systems preferred

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

At Novo Nordisk, were not chasing quick fixes - were creating lasting change for long-term health. For over 100 years, weve been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of whats possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, were making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger - a legacy of impact that reaches far beyond today.

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.

About the Company

N

Novo Nordisk AS

Working at Novo Nordisk

 

Life-changing careers

Starting a career at Novo Nordisk is more than getting a job. It is an opportunity to improve the lives of millions of people living with a serious chronic disease.

Whether you are a part of supplying insulin for patients around the world, discovering the next breakthrough at one of our state-of-the-art research centres, working with us is truly life-changing.

 

We are inspired by life

We are a proud life-science company on a mission to ensure that people living with a chronic disease can live a full life. Millions rely on us.

We’re inspired by life in all its forms and shapes, ups and downs, opportunities and challenges. From our colleagues in the lab, working to change lives through pioneering break-through treatments, to our colleagues putting sustainability at the core of our processes and working to prolong the life of our planet, this mission to improve lives is at the core of our every action.

 

Together we drive change

Change is a constant — change in lifestyle, change in technology, change all over. At Novo Nordisk, we don’t wait for change. We drive it.

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.

That’s why we continuously push to improve the way we work and the lives of the patients we serve, creating innovative solutions that fit the way people want to live. To accomplish this, we embrace a spirit of open-mindedness and experimentation, striving for excellence without fixating on perfection.

 

Together, we are life-changing

Our company is our people. We know that life is anything but linear and balancing what is important at different stages of our career is never easy. That’s why we make room for diverse life situations, always putting people first. We want to ensure that every employee can achieve a work-life balance that supports their current priorities and where they want to go next.

 

Your development starts here

We value our employees for the unique skills, backgrounds and perspectives they bring to the table. We work continuously to help bring out the best in all of our people, offering opportunities for development and creating an environment of mobility within the company. We strive to offer a workplace that’s great to be in and to be from.

It is very important to us that anyone working with us feels empowered as an employee and as a person. We all should have the opportunity to act fast, make decisions and be agile. 

With a career at our company, you will feel a difference right from the start. A sense of inspiration that comes from a shared belief in driving positive change for people, families and communities everywhere, and it’s a collective effort. We rely on the joint potential and collaboration of our more than 45,000 employees.

In the video above, meet  Marie Darting, one of our scientists, and hear more about her work as a formulation scientist, her perspective on development plans and the impact she feels her work has on people living with a chronic disease.

 

Who we are

We were founded in 1923 and today we are a global healthcare company headquartered just outside Copenhagen, Denmark.

Our purpose is to drive change to defeat diabetes and other serious chronic diseases, such as obesity and rare blood and endocrine disorders. We do so by pioneering  scientific breakthroughs, expanding  access to our medicines , and working to prevent and ultimately cure diabetes.

With almost 100 years of experience, one of the broadest diabetes product portfolios in the healthcare industry, as well as an award-winning pipeline of innovative products, our success is built on our company values – the Novo Nordisk Way.

COMPANY SIZE
2,500 to 4,999 employees
INDUSTRY
Biotechnology/Pharmaceuticals
FOUNDED
1923
WEBSITE
https://www.novonordisk.com/