Process Specialist

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 employs approximately 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 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 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 Provide process, technical and strategic support to the organization as the Site Subject Matter Expert (SME) for department. Lead and support various projects as required based on evolving business needs. Act as a coach/mentor to area Process Professionals. Communicate on behalf of Novo Nordisk with Vendors, Engineering Firms, etc. related to projects and technical issues. Complete assigned projects and project tasks within cost, quality, and schedule requirements. Present project status updates to Senior Management. Relationships Reports to Manager/Director. The role is responsible for collaborating with stakeholders related to assigned area as well as other stakeholders across the site and other NN sites. Essential Functions Support production senior leadership as part of the department management group through participating in strategic discussions and decision making. Responsible for area content and process knowledge, periodic reviews, validation processes, and reporting. Demonstrate technical knowledge of assigned processes to promote continuous improvement, increased productivity, and cost reduction. Facilitate and provide technical oversight for assigned processes, including assessment of deviations, root cause analysis, validation and process changes/improvements. Evaluate process/maintenance data to propose, guide and evaluate solutions for changes and continuous process improvements via Lean tools and Six Sigma methodologies. Present as the technical expert for assigned processes to auditors/inspectors regarding complex subject matter. Collaborates and shares best practices with other departments and other sites of NN. Provide support to other areas in matters related to knowledge of assigned production/process area. Responsible for identifying and implementing process needs and improvement opportunities. Define and support the achievement of department goals according to company objectives and strategies. Lead and provide guidance related to complex maintenance matters. Communicate production and industry trends to team and shop floor to drive cGMP. Implement new technologies for the process/maintenance, planning and coordinating of changes according to applicable regulatory procedures. Follow all safety & environmental requirements in the performance of duties. Other accountabilities, as assigned. Physical Requirements Ability to work in an open office environment with the possibility of frequent distraction. Ability to travel up to 10% 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) from an accredited university required May consider an Associate’s degree (engineering, technology or related field of study) from an accredited university with a minimum of ten (10) years of manufacturing experience required May consider a High School Diploma (GED) with a minimum twelve (12) years of manufacturing experience preferred Minimum of eight (8) years of manufacturing experience required, preferably in a pharmaceutical manufacturing environment; ten (10) years preferred Thorough investigation and systematic problem‑solving experience required LEAN manufacturing experience and training required Excellent written communication skills, investigative writing and computer skills required Ability to read, write and understand complicated product documentation and standard operating procedures with attention to high level concepts required Ability to drive continuous improvements via Lean tools and Six Sigma methodologies required Proven expertise in planning/organizing, managing execution, checking results, revising plans required Comprehensive knowledge of change control systems and Quality Management Systems (QMS) required Thorough validation knowledge and experience required (product/tech transfer preferred) General experience with regulatory audits/inspections required Thorough knowledge of relevant electronic manufacturing system and master data required (ex: SAP, PAS‑X, etc.) Demonstrated knowledge of adult learning methodologies and ability to use multiple methods to train and coach others required 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 Initial Therapeutics, Inc.