Associate Process Engineer - API (Recovery)

Novo Nordisk; Clayton (NC); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Performance bonus

Paid holidays

Health insurance

401K with match

Parental leave

Product access

Tuition assistance

Life & disability

Referral awards

Job summary

Novo Nordisk in Clayton, NC is seeking a designed-focused engineer to provide routine support and troubleshooting for the manufacturing facility. You will input, review and approve design and requirement documents, as well as technical specifications, while coordinating with project teams and site stakeholders.

The role emphasizes GMP familiarity, process knowledge, and risk assessments, with career growth in a global healthcare leader dedicated to diabetes care.

Qualifications

• Bachelor’s degree in engineering, science, or a relevant technical field is required.
• Associate degree plus at least 2 years engineering/technical experience is acceptable.
• High school diploma with four years of engineering/technical experience is acceptable.
• At least one year of engineering/technical experience is preferred, preferably GMP-regulated.
• Experience with design of requirements documents is a plus.
• Experience in a GMP-regulated environment is preferred.
• Knowledge of FDA requirements and regulatory expectations is a plus.

Responsibilities

• Support development of design & requirement specifications documents.
• Support quality of equipment & processes.
• Assist in creating risk assessments such as RRA.
• Participate in creating a cGMP project statement.
• Create and participate in Quality Risk Management assessments.
• Support knowledge transfer from sponsor site.
• Ensure coordination between project and site stakeholders.
• Follow safety and environmental requirements in duties.

Education

Bachelor’s Degree in Engineering, Science, or relevant technical field

Associate’s Degree in Engineering, Science, or relevant technical field with 2+ years experience

High School Diploma or equivalent with 4 years engineering/technical experience

Tools

Process Control Systems

Job description

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-year 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 colour 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're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've 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 what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're 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.