Sterility Assurance SME (Process Professional II)

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. 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. 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 Support people, equipment and processes for our operations areas to meet business and regulatory requirements. Support training for lower-level peers. Demonstrate subject matter expertise in assigned area. Provide process solutions for moderate to high complexity issues. Serve as a back-up as needed for the Sr Process Professional and as a mentor/coach for junior team members. Relationships Reports to Manager. The role is responsible for collaborating with stakeholders related to assigned area. Support training for lower-level team members. Essential Functions Responsible for providing in depth deviation investigations and root cause analysis Drive continuous improvements via Lean tools and Six Sigma methodologies and certifications Responsible for area content and process knowledge Identify and implement process needs and improvement opportunities for moderate to high complexity issues Responsible for periodic reviews and reporting. Involved with collaboration across sites Update and manage area master data and recipes as needed Provide support on defined issues and contributes through application of expertise and knowledge Follow all safety & environmental requirements in the performance of duties Other duties as assigned Physical Requirements Ability to work in an open office environment with the possibility of frequent distraction. Ability to travel up to 20% of the time (% can change on a case by case basis based on the role.) Qualifications Bachelor’s degree (engineering, technology or related field of study preferred) from an accredited university required May consider an Associate’s degree (engineering, technology or related field of study preferred) in technology or related field of study from an accredited university with a minimum of four (4) years of manufacturing experience required, preferably in a pharmaceutical manufacturing environment May consider a High School Diploma (GED) with a minimum of six (6) years of manufacturing experience required, preferably in a pharmaceutical manufacturing environment Minimum of two (2) years of manufacturing experience required, preferably in a pharmaceutical manufacturing environment Excellent written communication skills required Thorough investigation and systematic problem-solving experience required LEAN manufacturing experience and training required General knowledge of change control systems and Quality Management Systems (QMS) required Relevant electronic manufacturing system experience required (ex: SAP, PAS-X, etc.) Demonstrated knowledge of adult learning methodologies and ability to use multiple methods to train and coach others preferred General experience with regulatory audits/inspections required Knowledge of relevant master data preferred Validation experience preferred Product transfer (or tech transfer) experience a plus We 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. #J-18808-Ljbffr BioSpace