Sterility Assurance SME (Process Professional II)
Novo Nordisk
August 18, 2026
On-site
Clayton, NC
Operations
The Position
Support people, equipment, and processes for operations 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 mentor/coach junior team members.
Essential Functions
- Provide in-depth deviation investigations and root cause analysis
- Drive continuous improvements using Lean tools and Six Sigma methodologies and certifications
- Own area content and process knowledge
- Identify and implement process needs and improvement opportunities (moderate to high complexity)
- Perform periodic reviews and reporting; collaborate across sites
- Update and manage area master data and recipes
- Support defined issues using expertise and knowledge
- Follow all safety and environmental requirements
Qualifications
- Bachelor’s degree (engineering/technology or related field) from an accredited university (required)
- OR Associate’s degree with 4+ years manufacturing experience (preferably pharma)
- OR High school/GED with 6+ years manufacturing experience (preferably pharma)
- 2+ years manufacturing experience (preferably pharma)
- Excellent written communication
- Thorough investigation and systematic problem-solving
- Lean manufacturing experience and training
- Change control and QMS knowledge
- Electronic manufacturing systems experience (e.g., SAP, PAS-X)
- Adult learning methodologies; ability to train/coach (preferred)
- Regulatory audit/inspection experience (required)
- Master data knowledge (preferred)
- Validation experience (preferred)
- Product/tech transfer experience (plus)
Benefits (as listed)
- Leading pay; annual performance bonus
- 14 paid holidays and generous paid time off
- Health, dental, vision insurance (effective day one)
- 8% 401K contribution plus possible company match
- 14 weeks paid parental and 6 weeks paid family medical leave
- Free access to Novo Nordisk-marketed pharmaceutical products
- Tuition assistance; life and disability insurance; employee referral awards
Application instruction
For special assistance or accommodation to apply, call 1-855-411-5290.
Support people, equipment, and processes for operations 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 mentor/coach junior team members.
Essential Functions
- Provide in-depth deviation investigations and root cause analysis
- Drive continuous improvements using Lean tools and Six Sigma methodologies and certifications
- Own area content and process knowledge
- Identify and implement process needs and improvement opportunities (moderate to high complexity)
- Perform periodic reviews and reporting; collaborate across sites
- Update and manage area master data and recipes
- Support defined issues using expertise and knowledge
- Follow all safety and environmental requirements
Qualifications
- Bachelor’s degree (engineering/technology or related field) from an accredited university (required)
- OR Associate’s degree with 4+ years manufacturing experience (preferably pharma)
- OR High school/GED with 6+ years manufacturing experience (preferably pharma)
- 2+ years manufacturing experience (preferably pharma)
- Excellent written communication
- Thorough investigation and systematic problem-solving
- Lean manufacturing experience and training
- Change control and QMS knowledge
- Electronic manufacturing systems experience (e.g., SAP, PAS-X)
- Adult learning methodologies; ability to train/coach (preferred)
- Regulatory audit/inspection experience (required)
- Master data knowledge (preferred)
- Validation experience (preferred)
- Product/tech transfer experience (plus)
Benefits (as listed)
- Leading pay; annual performance bonus
- 14 paid holidays and generous paid time off
- Health, dental, vision insurance (effective day one)
- 8% 401K contribution plus possible company match
- 14 weeks paid parental and 6 weeks paid family medical leave
- Free access to Novo Nordisk-marketed pharmaceutical products
- Tuition assistance; life and disability insurance; employee referral awards
Application instruction
For special assistance or accommodation to apply, call 1-855-411-5290.