Finished Production Technical Specialist - FFEx

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.

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 which we 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 12 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 assigned specialized area (ex. Filling, Process Automation, Utilities, etc.) and serve as Local representative of ManDev onsite. Lead and support various projects as required based on evolving business needs. Act as a coach/mentor to Process Specialists-AP/FP/Utilities. Communicate on Novo Nordisk behalf with Vendors, Engineering Firms, etc. Complete assigned projects and project tasks within cost, quality, and schedule requirements. Present project status updates to Senior Management.

 

Relationships

Senior Manager; Director; AP/FP Equip or Manager, FUSE.

 

Essential Functions

• Provide technical oversight for assigned processes, including assessment of deviations, validation, and changes/improvements
• Support Production senior leadership as part of the department's management group through participating in strategic discussions and decision-making
• Lead and provide guidance related to documentation applicable to the process, maintenance, and regulatory standards
• Serve as the technical expert related to complex maintenance matters
• Define and support the achievement of department goals according to company objectives and strategies
• Propose, guide, and evaluate solutions for process/maintenance changes and continuous process improvements
• Implement new technologies for the process/maintenance, planning and coordinating of changes according to applicable regulatory procedures
• Communicate production and industry trends to team and shop floor to drive cGMP
• Facilitate problem solving, investigations, and process improvements
• Communicate across all levels of the organization (Entry-level operator level to CVP) as a technical expert, to include ability to influence internal stakeholders in resolution of disagreements
• Evaluate process/maintenance data, stability studies and prepare reports
• Responsible for validation processes
• Demonstrate technical knowledge of assigned processes to promote continuous improvement, increased productivity, and cost reduction
• Present as the technical expert for assigned processes to auditors/inspectors regarding complex subject matter
• Share best practices with other departments and areas of NN
• Provide support to other areas in matters related to knowledge of assigned production/process area
• 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 in related field of study from an accredited university required
• Equivalent combination of education and internal NN experience may be considered
• Minimum of ten (10) years of manufacturing experience required,