Sterility Assurance SME; Process Professional II

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.

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.

• 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.

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.

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

Responsible for providing in depth deviation investigations and root cause analysis

Drive continuous improvements via Lean tools and Six Sigma methodologies and certifications

Responsible for area content and process knowledge

Identify and implement process needs and improvement opportunities for moderate to high complexity issues

Responsible for periodic reviews and reporting. Involved with collaboration across sites

Update and manage area master data and recipes as needed

Provide support on defined issues and contributes through application of expertise and knowledge

Follow all safety & environmental requirements in the performance of duties

Other duties as assigned

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.)

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…