Process Engineer I - Printed Packaging Material - SDF

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 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 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 an ongoing 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 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. #J-18808-Ljbffr Novo Nordisk A/S