Process Area Specialist - FFEx [Finished Production - Assembly] at Novo Nordisk

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

Support people, equipment and processes for our operations areas to meet business and regulatory requirements. Support training for lower-level peers. Demonstrate subject matter expertise in assigned area. Provide process solutions for moderate to high complexity issues. Serve as a back-up as needed for the Sr Process Professional and as a mentor/coach for junior team members.

 

Relationships

Manager. The role is responsible for collaborating with stakeholders related to assigned area. Support training for lower-level team members.

 

Essential Functions

•   Provide process expertise on process execution, resolving process needs, and driving improvement opportunities.
•    Coach and lead investigations for process-related issues, mentoring Area Specialists for their growth and development.
•    Ensure department documents are current and standardized, maintaining compliance with industry standards.
•    Communicate production and pharmaceutical industry trends, ensuring cGMP standards are upheld on the shop floor.
•    Serve as a Subject-Matter Expert (SME) for assigned processes, participating in Process Group activities as required.
•    Drive improvement activities based on process performance and event response across all sites.
•    Monitor process performance on-site and report performance to the Process Group Chairperson.
•    Participate in event response activities and share solutions across sites within the expansion.
•    Drive projects to evaluate and implement process improvement ideas locally and across sites within the expansion.
•    Ensure continuous improvement of framework standards through a structured standards management process.
•    Collaborate with international teams to meet hiring, training, and ramp-up goals for new processes.
•    Assist with training development and on-boarding processes as needed.

 

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 preferred) from an accredited university required

May consider an Associate’s degree (engineering, technology or related field of study preferred) in technology or related field of study from an accredited university with a minimum of four (4) years of manufacturing experience required, preferably in a pharmaceutical manufacturing environment

May consider a High School Diploma (GED) with a minimum of six (6) years of manufacturing experience required, preferably in a pharmaceutical manufacturing environment

Minimum of two (2) years of manufacturing experience required, preferably in a pharmaceutical manufacturing environment

Excellent written communication skills required

Thorough investigation and systematic problem-solving experience required

LEAN manufacturing experience and training required

General knowledge of change control systems and Quality Management Systems (QMS) required

Relevant electronic manufacturing system experience required (ex: SAP, PAS-X, etc.)

Demonstrated knowledge of adult learning methodologies and ability to use multiple methods to train and coach others preferred

General experience with regulatory audits/inspections required

Knowledge of relevant master data preferred

Validation experience preferred

Product transfer (or tech transfer) experience a plus

 

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.