Sterility Assurance SME (Process Professional II)

BioSpace; Clayton (NC); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

8% 401K company match

Parental & family leave

Tuition assistance

Life & disability insurance

Employee referral rewards

Job summary

Novo Nordisk is seeking a Process Professional to support operations, people, equipment, and processes in aseptic production and fill/finish. You will mentor junior staff, back up senior team members, and apply subject matter expertise to solve moderate to high complexity issues while ensuring regulatory compliance.

The role emphasizes Lean/Six Sigma, process data management, and collaboration across sites in a dynamic global manufacturing environment.

Qualifications

• Bachelor’s degree (engineering, technology or related field) from an accredited university required.
• Associate’s degree with minimum 4 years manufacturing experience preferred.
• High School Diploma with minimum 6 years manufacturing experience preferred.
• Minimum 2 years of manufacturing experience in pharmaceutical environment preferred.
• Excellent written communication skills.
• LEAN manufacturing experience and training required.
• General knowledge of change control systems and QMS required.
• Regulatory audits/inspections experience preferred.
• Knowledge of master data and electronic manufacturing systems (e.g., SAP, PAS-X) preferred.

Responsibilities

• Perform in-depth deviation investigations and root cause analysis.
• Drive continuous improvement using Lean tools and Six Sigma methods.
• Maintain area content and process knowledge.
• Identify and implement improvement opportunities for moderate to high complexity issues.
• Collaborate across sites and manage area master data and recipes as needed.
• Provide support on defined issues using subject matter expertise.
• Follow safety and environmental requirements in daily duties.
• Support training for junior team members.

Skills

Lean manufacturing

Problem solving

Written communication

Regulatory audits

QMS knowledge

Adult learning methods

Change control systems

GxP systems knowledge

Root cause analysis

Education

Bachelor's degree in engineering/tech

Associate's degree with 4+ years experience

High School Diploma with 6+ years experience

Tools

SAP

PAS-X

Job description

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 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

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

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

Essential Functions

• 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

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're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

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.