Senior Engineer, MS&T

At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. 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.

At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. 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.

Our Bloomington, Indiana site is a state-of-the-art facility where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The Bloomington campus is a recognized facility where talented teams work with innovators to help develop, manufacture and supply products to patients around the world.

• 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.

Provide technical expertise and leadership to support technology transfer, process optimization and lifecycle management of manufacturing processes. Partner with cross-functional teams to ensure reliable, compliant and efficient operations while driving continuous improvement, process robustness and successful product delivery in alignment with Novo Nordisk's strategic objectives and quality standards.

Reports to Manager or above.

• Perform as a subject matter expert (SME) for a Drug Substance operation (e.g., production bioreactor processes, chromatography, tangential flow filtration, etc.)
• Utilize Process Development and client provided process data to review proposed GMP scale process descriptions. Create process flow diagrams from process descriptions
• Perform responsibilities associated with the evaluation, alignment and recommendation of equipment and process improvements
• Review daily processing data from GMP manufacturing to monitor process performance
• Authors and approves technical documents, such as batch records, protocols, bills of materials, sample plans, manufacturing campaign reports, operating procedures, etc
• Review technical and validation documents for accuracy and thoroughness
• Perform assessments on material changes as disclosed by suppliers
• Train others on manufacturing techniques and science/engineering principles
• Participate in client meetings offering technical support and act as the lead representative for MS&T
• Work cross functionally with Process Development, Manufacturing, Engineering, Automation, Quality Assurance, Quality Control, Supply Chain, Project Management, Validation, Facilities and other departments to effectively transfer and maintain processes in the facility
• Participate in and support strategic alignment across Biologics sites and the Bloomington site
• Work closely with manufacturing to author appropriate batch documentation and provide technical and strategic oversight associated with GMP manufacturing
• Lead and/or support the compilation of process data, including communicating project status, trend identification and delivering internal or client presentations
• Evaluate existing processes and identify process or equipment improvements to advance efficiency, consistency and competitiveness within the market
• Support the building of business case(s) for process improvement projects
• Act as the lead for technical support of risk assessments, gap analysis, deviations, change controls and CAPAs including determination of product or process impact, root-cause analysis and corrective action identification
• Responsible for motivating, coaching and developing coworkers as a subject matter expert
• Act as a mentor to lower-level team members and Co-ops/interns
• Perform other responsibilities to support group, site and network-based initiatives, as…