Process Engineer I - Printed Packaging Material - SDF

Novo Nordisk A/S; Durham (NC); On-site; USD 75,000 - 95,000; Full time

Benefits offered by this job

Health Insurance

Dental Insurance

Vision Insurance

401K

Job summary

Novo Nordisk A/S in Durham, NC seeks a Process Engineer I to support Finished Production – Packaging, ensuring compliance of internal processes and supplier agreements for Printed Packaging Material. You will drive improvements and act as a project lead for PPM optimization.

The role requires a GMP background, strong problem-solving and data analysis skills, and collaboration with internal and external stakeholders to deliver high-quality packaging outcomes.

Qualifications

• Bachelor’s Degree in Engineering, Science, or relevant technical field from an accredited university; minimum 1 year of engineering or technical experience, preferably GMP.
• Associate’s Degree in Engineering, Science, or relevant field; minimum 3 years engineering/technical experience, preferably GMP.
• High School Diploma or equivalent with minimum 5 years engineering/technical experience, preferably GMP.
• Minimum of 4 years packaging/production/production quality support experience, preferably GMP-regulated environment.
• Experience in PPM manufacturing a plus.
• Owning process improvement initiatives preferred.
• Experience in production environment highly dependent on input components required.
• Experience handling nonconformities & changes in GMP-regulated industry preferred
• Strong quality mindset and detail-oriented approach preferred
• Knowledge of PPM specifications, PPM manufacturing & QMS methods to understand root cause investigations & CA/PA preferred
• Knowledge of production processes and how input components impact finished goods

Responsibilities

• Identify opportunities to drive process improvements related to Printed Packaging Material (PPM).
• Evaluate and input on PPM-related complaints from production.
• Provide Nonconformity and Change-Request input for PPM issues.
• Serve as site contact for PPM-related issues.
• Perform trending and data analysis on improvement opportunities for PPM specs.
• Drive systematic problem solving with internal and external stakeholders.
• Act as Project Manager for optimization of PPM processes.
• Provide input for Deviations & Change Requests related to PPM for finished production packaging.
• Ensure GxP/ISO compliance for PPM.
• Participate in quality meetings with suppliers and production lines.
• Assist in Out of Specification assessments and anchoring improvements.
• Support supplier compliance monitoring and trend analysis with Business Support.
• Partner with manager on supplier evaluations.
• Other accountabilities as assigned.

Skills

Process improvement

Data analysis

Project management

GxP knowledge

Communication

Problem solving

Education

Bachelor's in Engineering/Science

Associate's in Engineering/Science

High School diploma + 5 years experience

Tools

GxP systems

QMS

IT systems

Job description

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Process Engineer I - Printed Packaging Material - SDF

Location: 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 14weeks 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
• 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
• 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.