Process Engineer I - Printed Packaging Material

Novo Nordisk AS

Clayton, NC

JOB DETAILS
SKILLS
Asepsis, Biotech and Pharmaceutical, Business Support, Change Requests/Orders, Chronic Disease, Communication Skills, Data Analysis, Dental Insurance, Detail Oriented, Disability Insurance, Disease, Dosage Forms, GMP (Good Manufacturing Practices), GxP, Hazardous Materials/Substances, Health Insurance, Healthcare, ISO (International Organization for Standardization), Life Insurance, Maintain Compliance, Manufacturing, Manufacturing Equipment, Manufacturing Methods, Mentoring, Organizational Skills, Pallet Jack, Problem Solving Skills, Process Engineering, Process Improvement, Product Marketing, Production Support, Production Systems, Project Planning, Project Portfolio Management (PPM), Project/Program Management, Quality Control, Regulations, Root Cause Analysis, Trend Analysis, Tuition Fees, Vendor/Supplier Evaluation, Vision Plan, Warehousing
LOCATION
Clayton, NC
POSTED
5 days ago

About the Department

You will be joining Fill & Finish Expansions (FFEx), which is responsible for all major expansion activities within aseptic production, solid dosage forms, finished products, fill & finish warehousing, and QC across all production areas in Product Supply. The area is anchored in Product Supply, Quality & IT, which globally employ approx. 20,000 of Novo Nordisk's 50,000 employees.

FFEx is a newly established and growing area with the responsibility to design, plan, and build all new aseptic filling capacity across Novo Nordisk to serve the needs of millions of patients. We do it by rethinking our production facilities with the use of modern technology, as we are setting the standards for the aseptic production of the future. Facilities designed today which we will still be proud of 20 years from now. FF Expansions has a global approach, where you will be working with multiple sites and cultures across the world.

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, IFP Clayton.

Relationships

Reports to Manager, FP Process & Compliance.

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 Device Manufacturing Development related to PPM issues
  • 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 within IFP Clayton
  • 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 IFP Clayton
  • 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 compliance 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 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

  • Bachelors Degree in Engineering or related field, or equivalent combination of education & experience required
  • 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, were not chasing quick fixes - were creating lasting change for long-term health. For over 100 years, weve 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 whats possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, were 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.

About the Company

N

Novo Nordisk AS

Working at Novo Nordisk

 

Life-changing careers

Starting a career at Novo Nordisk is more than getting a job. It is an opportunity to improve the lives of millions of people living with a serious chronic disease.

Whether you are a part of supplying insulin for patients around the world, discovering the next breakthrough at one of our state-of-the-art research centres, working with us is truly life-changing.

 

We are inspired by life

We are a proud life-science company on a mission to ensure that people living with a chronic disease can live a full life. Millions rely on us.

We’re inspired by life in all its forms and shapes, ups and downs, opportunities and challenges. From our colleagues in the lab, working to change lives through pioneering break-through treatments, to our colleagues putting sustainability at the core of our processes and working to prolong the life of our planet, this mission to improve lives is at the core of our every action.

 

Together we drive change

Change is a constant — change in lifestyle, change in technology, change all over. At Novo Nordisk, we don’t wait for change. We drive it.

We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future.

That’s why we continuously push to improve the way we work and the lives of the patients we serve, creating innovative solutions that fit the way people want to live. To accomplish this, we embrace a spirit of open-mindedness and experimentation, striving for excellence without fixating on perfection.

 

Together, we are life-changing

Our company is our people. We know that life is anything but linear and balancing what is important at different stages of our career is never easy. That’s why we make room for diverse life situations, always putting people first. We want to ensure that every employee can achieve a work-life balance that supports their current priorities and where they want to go next.

 

Your development starts here

We value our employees for the unique skills, backgrounds and perspectives they bring to the table. We work continuously to help bring out the best in all of our people, offering opportunities for development and creating an environment of mobility within the company. We strive to offer a workplace that’s great to be in and to be from.

It is very important to us that anyone working with us feels empowered as an employee and as a person. We all should have the opportunity to act fast, make decisions and be agile. 

With a career at our company, you will feel a difference right from the start. A sense of inspiration that comes from a shared belief in driving positive change for people, families and communities everywhere, and it’s a collective effort. We rely on the joint potential and collaboration of our more than 45,000 employees.

In the video above, meet  Marie Darting, one of our scientists, and hear more about her work as a formulation scientist, her perspective on development plans and the impact she feels her work has on people living with a chronic disease.

 

Who we are

We were founded in 1923 and today we are a global healthcare company headquartered just outside Copenhagen, Denmark.

Our purpose is to drive change to defeat diabetes and other serious chronic diseases, such as obesity and rare blood and endocrine disorders. We do so by pioneering  scientific breakthroughs, expanding  access to our medicines , and working to prevent and ultimately cure diabetes.

With almost 100 years of experience, one of the broadest diabetes product portfolios in the healthcare industry, as well as an award-winning pipeline of innovative products, our success is built on our company values – the Novo Nordisk Way.

COMPANY SIZE
2,500 to 4,999 employees
INDUSTRY
Biotechnology/Pharmaceuticals
FOUNDED
1923
WEBSITE
https://www.novonordisk.com/