GCM EMTO Specialist - FP

About the Department
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 life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world.
In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our Product Supply Aseptic Manufacturing (PS AM) facility in Clayton, NC is a 457,000 square foot aseptic "fill and finish" site that is responsible for producing innovative, injectable diabetes and obesity treatments. At PS AM, 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 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
Serve as process subject matter expert (SME) for assigned CMO production/process area. Support people, equipment and processes for our operations areas to meet business and regulatory. Serve as lead and mentor/trainer for junior team members, to include supporting their training requirements.
Relationships
Senior 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

• Oversee area content and provide 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
• Identify and implement process needs and improvement opportunities for issues of all complexity levels as SME for assigned areas
• Implement new technologies for the process, planning and coordinating of changes according to applicable regulatory procedures
• Obtain insight into production operations and drive solutions whenever production disturbances occur
• Work closely to our team of EMTO FP (External Manufacturing Technology & Optimization Finished Production) area specialists & professionals and internal stakeholders ensuring the implementation of a robust production process at our CMO partners
• Gain extensive knowledge of the full external production life cycle such as the manufacturing, inspection and most importantly the assembly & packaging operations including critical equipment & processes
• Develop and maintain a strong interaction with Novo Nordisk Manufacturing development areas
• Provide procedural or process suggestions for achieving team goals; providing necessary competences and help to remove obstacles, ensuring the team accomplishes specific results
• 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 in pharmacy, Engineering, Automation, or relevant field of study from an accredited university required or equivalent combination of education & experience
• May consider an associate's degree in pharmacy, Engineering, Automation, or relevant field of study from an accredited university with a minimum of ten (10) years of experience in pharmaceutical manufacturing, including assembly, packing, and/or device assembly required, preferably in a pharmaceutical environment
• May consider a High School Diploma (GED) with a minimum of twelve (12) years of experience in pharmaceutical manufacturing, including assembly, packing, and/or device assembly required, preferably in a pharmaceutical environment
• Minimum of eight (8) years of experience in pharmaceutical manufacturing, including assembly, packing, and/or device assembly required, preferably in a pharmaceutical environment
• Thorough investigation and systematic problem-solving experience required
• LEAN manufacturing experience and training required
• Experience working in technology transfer projects, automation projects and/or life cycle management projects within pharmaceutical assembly/pack operations required
• Demonstrated knowledge in GMP practices required
• Good knowledge of overall practices for drug product manufacturing, aseptic filling process, quality management systems a plus
• Proven expertise in stakeholder management, cross-functional collaboration, independent work, training and coaching others 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.)

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing.
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 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.