Process Engineer I - Printed Packaging Material - SDF (Durham, NC, US)

About the Department

For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & obesity. 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 Emerging Technologies -Solid Dosage Forms US  facility in Durham, NC is a 194,000 square foot tableting and packaging facility that supports the production of our innovative oral treatments for patients with type 2 diabetes. SDF maintains a curious and pioneering spirit, harmonious with our growing pipeline of new products and emerging technologies.

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

The overall responsibility is to represent Finished Production – Packaging & assist in ensuring compliance of internal processes & the enforcement of supplier agreements according to specifications for the Novo Nordisk Production sites in North Carolina.

Relationships

Reports to Manager.

Essential Functions

Knowledgeable in assigned process to identify opportunities for, & drive process improvements related to Printed Packaging Material (PPM)

Identify, evaluate, & provide input on PPM related complaints coming from production

Responsible for providing Nonconformity & Change-Request input for PPM related issues

Site contact for issues related to PPM

Perform trending & data analysis on observed improvement opportunities for PPM specifications on on-going basis

Actively & independently drive systematic problem solving with internal & external stakeholders

Act as Project Manager for optimization of PPM processes

Provide input from Finished Production – Packaging for Deviations & Change Requests regarding Printed

Packaging Material (PPM) to ensure GxP/ISO compliance

Participate in quality meetings with suppliers & production lines at

Assist in performing Out of Specification (OOS) assessments & Own actions related to anchoring improvements

Support supplier compliance monitoring & trend analysis in partnership with Business Support

Partner with manager in executing supplier evaluations

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

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

Minimum of four (4) years of packaging, production, or production quality support experience, preferably in a GMP-regulated environment preferred

Previous experience in PPM manufacturing environment a plus

Previous experience in deviation handling (DV owner) preferred

Project Management experience preferred

Owning process improvement initiatives preferred

Proven experience within production environment that is highly dependent on input components required

Proven experience within handling of nonconformities & changes in a GMP regulated industry preferred

Strong Quality Mindset, proven detailed-oriented approach preferred

Knowledge of specification and requirement landscape for PPM, including PPM manufacturing & QMS methods to understand and challenge supplier root cause investigation & CA/PA preferred

Knowledge of production processes & how input components may impact quality of finished goods required

IT knowledge & understanding a plus

Data Analytics a plus

Demonstrated experience in practical problem solving & process improvement methods preferred

Knowledge of US, EU regulations & guidelines, GxP/ISO & application of GMP’s preferred

Ability to communicate technical information clearly in writing & presentations preferred

Challenging the status quo with innovative ideas aligned to innovation preferred

Experience planning, organizing, managing execution, checking results, & revising work plans preferred

Strong communication & stakeholder management skills across multiple organizational levels preferred

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.

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.

]]>