Wash & Sterilization Senior Process Professional - 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

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

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

• 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 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, 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.