Process Engineer I - Printed Packaging Material

About the DepartmentYou 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 AwardsAt 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 PositionThe 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.RelationshipsReports to Manager, FP Process & Compliance.Essential FunctionsKnowledgeable 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 productionResponsible for providing Nonconformity & Change-Request input for PPM related issuesSite contact for Device Manufacturing Development related to PPM issuesPerform trending & data analysis on observed improvement opportunities for PPM specifications on on-going basisActively & independently drive systematic problem solving with internal & external stakeholdersAct as Project Manager for optimization of PPM processes within IFP ClaytonProvide input from Finished Production – Packaging for Deviations & Change Requests regarding PrintedPackaging Material (PPM) to ensure GxP/ISO complianceParticipate in quality meetings with suppliers & production lines at IFP ClaytonAssist in performing Out of Specification (OOS) assessments & Own actions related to anchoring improvementsSupport supplier compliance monitoring & trend analysis in partnership with Business SupportPartner with compliance manager in executing supplier evaluationsOther accountabilities, as assignedPhysical RequirementsMoves 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.QualificationsBachelor's Degree in Engineering or related field, or equivalent combination of education & experience requiredMinimum 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 plusPrevious experience in deviation handling (DV owner) preferredProject Management experience preferredOwning process improvement initiatives preferredProven experience within production environment that is highly dependent on input components requiredProven experience within handling of nonconformities & changes in a GMP regulated industry preferredStrong Quality Mindset, proven detailed-oriented approach preferredKnowledge of specification and requirement landscape for PPM, including PPM manufacturing & QMS methods to understand and challenge supplier root cause investigation & CA/PA preferredKnowledge of production processes & how input components may impact quality of finished goods requiredIT knowledge & understanding a plusData Analytics a plusDemonstrated experience in practical problem solving & process improvement methods preferredKnowledge of US, EU regulations & guidelines, GxP/ISO & application of GMP’s preferredAbility to communicate technical information clearly in writing & presentations preferredChallenging the status quo with innovative ideas aligned to innovation preferredExperience planning, organizing, managing execution, checking results, & revising work plans preferredStrong communication & stakeholder management skills across multiple organizational levels preferredWe 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 View phone number on click.appcast.io. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.