Process Engineer I - FFEx - Printed Packaging Material

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 12 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

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 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 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 we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

 

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.