Senior Process Professional

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 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 457000 square foot aseptic fill and finish site that is responsible for producing innovative injectable diabetes and obesity treatments. At PS AM youll 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 14weeks 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 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

Reports to Manage/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
• 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 20% of the time. (% can change on a case-by-case basis based on the role)

Qualifications

• Bachelors degree (engineering technology or related field of study) from an accredited university required
  • May consider an Associates degree (engineering technology or related field of study) from an accredited university with a minimum of seven (7) years of manufacturing experience required
  • May consider a High School Diploma (GED) with a minimum nine (9) years of manufacturing experience required
• Minimum of five (5) years of manufacturing experience required preferably in a pharmaceutical manufacturing environment
• 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 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 were 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-. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.