Associate Process Engineer – API

Novo Nordisk

Provide engineering support for the manufacturing facility at Novo Nordisk. Responsible for development of design specifications, quality processes, and collaboration with engineering suppliers.

Posted 5/27/2026full-timeClayton • North Carolina • 🇺🇸 United StatesJuniorMid-LevelWebsite

About the role

Key responsibilities & impact

Provide routine support & troubleshooting for the manufacturing facility.
Primary tasks: provide input, review & approve design & requirement documents; provide input, review & approve technical specifications.
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 workshops 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

Requirements

What you’ll need

Bachelor’s Degree in Engineering, Science, or relevant technical field of study from an accredited university required
Bachelor's degree in engineering/related field or anticipated Bachelor's degree in engineering/related field by 6/30/26 required, or within 12 months of application 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.

Benefits

Comp & perks

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

ATS Keywords

✓ Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

design documentstechnical specificationsquality risk managementrisk assessmentsprocess FMECAprocess flow diagramscapacity calculationsprocess control systemsGMP regulationsengineering experience

Soft Skills

collaborationcommunicationnetworkingknowledge transferself-developmenttroubleshootingcoordinationinput reviewparticipation in workshopssupport for operational business

Certifications

Bachelor's Degree in EngineeringBachelor's Degree in ScienceAssociate's Degree in EngineeringHigh School Diploma