Process Engineer II/III - Cleaning Validation

About the Department In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. The newer Active Pharmaceutical Ingredients (API) facility in Clayton, NC sits on 825,000 square feet of state‑of‑the‑art equipment, and houses the Fermentation, Recovery, and Purification in the production of ingredients for Novo Nordisk’s innovative oral products. At API, you’ll join a global network of manufacturing professionals who are passionate about what they do. 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, dental, and vision insurance – effective day one Guaranteed 8% 401(k) contribution plus individual company match option Family focused benefits including 14 weeks paid parental and 6 weeks paid family medical leave Free access to Novo Nordisk‑marketed pharmaceutical products Tuition assistance Life and disability insurance Employee referral awards The Position Support the ongoing development of the department processes. Support daily operations as well as continuous improvement of department processes including ensuring system and equipment reliability to meet customer, business, and regulatory requirements. Provide routine support and troubleshooting for the manufacturing facility. Relationships Reports to Manager and Senior Manager. Essential Functions Support operations within the area through process knowledge sharing, critical decision making, and strategy Drive equipment qualification, optimization, and validation within the area, and maintain quality of equipment and processes Coach and mentor team members Drive process monitoring activities for key process parameters and track initiatives Ensure identification of and collaboration regarding interfaces to other processes and support systems Ensure coordination and collaboration between site stakeholders Gather and ensure knowledge transfer to project from other similar production sites in Novo Nordisk Own self‑development and partner with manager for clear understanding of development needs for desired career path Generate improvement concepts, justify, and implement across track Follow all safety and environmental requirements in the performance of duties Other duties as assigned Physical Requirements Moves equipment and or supplies weighing up to 33 pounds within the facility using various body positions. Routinely operates and inspects manufacturing equipment using hands. Strap and 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, color vision, or other sensory adjustments. Occasionally ascends/descends a ladder, works at elevated heights, or works around odorous or hazardous materials. May require wearing latex gloves or other protective gear. May perform critical job functions in extremely cold work environments depending on the site. May need to secure a motorized vehicle license and operate a motorized vehicle as part of the role. Qualifications Bachelor’s degree in Engineering, Science, or a relevant technical field of study from an accredited university is required. May consider an Associate’s degree with six (6) years of relevant experience in a GMP‑regulated environment. May consider a High School diploma or equivalent with eight (8) years of relevant experience in a GMP‑regulated environment. Minimum four (4) years of engineering or technical experience, preferably in a GMP‑regulated environment. CLEAN 1Star certification is required. Knowledge of requirements or expectations from authorities (e.g., FDA) preferred. Proven ability to establish and maintain networks and facilitate processes that encourage cross‑organizational knowledge sharing preferred. Experience with process control systems, design of requirements documents, and functional knowledge across tracks with expertise in one or more operations preferred. Ability to provide support for a 24/7 operational business is required. Equal Opportunity Statement We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. 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. #J-18808-Ljbffr BioSpace