Associate Process Engineer – API Position Available In Johnston, North Carolina

Associate Process Engineer – API
Employer
Novo Nordisk
Location
Clayton, NC
Start date
Apr 29, 2025
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Company
Job Details 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 life-changing careers, and 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 Provide routine support & troubleshooting for the manufacturing facility.

Primary tasks:

provide input, review & approve design & requirement documents; provide input, review & approve technical specifications. Relationships Reports to Manager or Senior Manager. Essential Functions Support development of design & requirement specifications documents
Support quality of equipment & processes
Support the creation of process tracks risk assessment documents, such as Requirement Risk Assessments (RRA’s)
Participation in the creation of a project cGMP Statement
Create & participate in Quality Risk Management (QRM) risk assessments, such as Closed-Process, Cross-Contamination, Contamination & Facility flows
Own self development and partner with manager for clear understanding of development needs for desired career path
Input & review to Process FMECA’s for the Process tracks
Participation in design work shops with engineering suppliers
Input & review of Process Module Diagrams, & Process Flow Diagrams
Input & review of Process Scheduling & Capacity Calculations
Support package in maintaining schedule adherence
Ensure coordination & collaboration between project & other site stakeholders
Gather & ensure knowledge transfer to project from DK sponsor site
Follow all safety & environmental requirements in the performance of duties
Other duties 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 Bachelor’s Degree in Engineering, Science, or relevant technical field of study from an accredited university required
May consider an Associate’s Degree in Engineering, Science, or relevant technical field of study from an accredited university with a minimum of two (2) years of engineering or technical experience required, preferably in a GMP regulated environment
May consider High School Diploma or equivalent with four (4) years of engineering or technical experience required, preferably in a GMP regulated environment
A minimum of one (1) year of engineering or technical experience preferred, preferably in a GMP regulated environment
Experience with design of requirements documents a plus
Experience working in a GMP regulated environment preferred
Knowledge about requirements/expectations of regulatory authorities e.g. FDA a plus
Experience with Process Control Systems a plus Proven ability to establish & maintain networks & facilitate processes that encourage cross organizational knowledge sharing a plus
Ability to provide support for a 24/7 operational business required 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. 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. Company Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in 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 disease. Novo Nordisk employs about 54,400 people in 80 countries and markets its products in around 170 countries. For more information visit novonordisk. Our US Research & Development hub, located in the Greater Boston area, brings together the best talent to drive life science innovation. Located in Lexington, Watertown and Cambridge, our teams reflect the full scope of R D, from early research through late-stage clinical development. We are building for the future by creating a distinct R D community based on collaboration, partnerships, and cutting-edge research across multiple modalities and therapeutic areas. We recognize that improving human health starts here and that patients rely on us. By combining the speed and agility of biotech with the quality, resources, and stability of a large pharmaceutical company, our US R D hub will benefit from the best of both worlds to develop new medicines that meet the needs of patients. CONNECT Company info