Process Engineer I - API

BioSpace; Clayton (NC); On-site; USD 70,000 - 105,000; Full time

Job summary

Novo Nordisk in Clayton, NC seeks a Manufacturing Engineer to provide routine support and troubleshooting for the facility's core processes, improving system reliability and ensuring compliance with customer, business, and regulatory requirements.

The role requires collaboration with cross‑functional teams, participation in validation and verification activities, implementation of process improvements, and support for 24/7 operations.

Qualifications

• Bachelor’s Degree in Engineering, Science, or relevant technical field from an accredited university required with a minimum of one (1) year of engineering or technical experience required, preferably in a GMP regulated environment
• Associate’s Degree in Engineering, Science, or relevant technical field from an accredited university with a minimum of three (3) years of engineering or technical experience required, preferably in a GMP regulated environment
• High School Diploma or equivalent with a minimum of five (5) years of engineering or technical experience required, preferably in a GMP regulated environment
• Functional knowledge in assigned area required
• Ability to work in a team required
• 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

Responsibilities

• Support validation & verification within area
• Ensure quality of equipment and processes
• Support process improvement project for assigned area
• Support manufacturing operations and provide technical support to the operating facilities to meet business goals
• Generate ideas & support implementation for improvement within area
• Own self development and partner with manager for clear understanding of development needs for desired career path
• Follow all safety & environmental requirements in the performance of duties
• Other duties as assigned

Skills

Engineering knowledge

Teamwork

Regulatory awareness

Education

Bachelor’s degree in Engineering/Science

Associate’s degree in Engineering/Science

High School Diploma

Tools

Process Control Systems

GMP environment experience

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.

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.

The Position

Provide routine support & troubleshooting for the manufacturing facility. Improve system and equipment reliability for the core processes to meet customer, business, & regulatory requirements.

Relationships

Reports to Manager or Senior Manager.

Essential Functions

• Support validation & verification within area
• Ensure quality of equipment and processes
• Support process improvement project for assigned area
• Support manufacturing operations and provide technical support to the operating facilities to meet business goals
• Generate ideas & support implementation for improvement within area
• Own self development and partner with manager for clear understanding of development needs for desired career path
• 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 with a minimum of one (1) year of engineering or technical experience required, preferably in a GMP regulated environment
• May consider an Associate’s Degree in Engineering, Science, or relevant technical field of study from an accredited university with a minimum of three (3) years of engineering or technical experience required, preferably in a GMP regulated environment
• May consider High School Diploma or equivalent with a minimum of five (5) years of engineering or technical experience required, preferably in a GMP regulated environment

Experience With Design Of Requirements Documents a Plus

• Functional knowledge in assigned area required
• Ability to work in a team required
• 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.

This contact is for accommodation requests only and cannot be used to inquire about the status of applications.