Process Professional II

Role Summary

The Process Professional II supports people, equipment, and processes in Novo Nordisk's Durham, NC operations to meet business and regulatory requirements. The role includes training lower-level peers, applying subject matter expertise in the assigned area, and delivering process solutions for moderate to high complexity issues. The role also serves as a back-up for the senior Process Professional and mentors junior team members, collaborating with stakeholders across sites.

Responsibilities

• Provide in-depth deviation investigations and root cause analysis
• Drive continuous improvements via Lean tools and Six Sigma methodologies
• Maintain area content and process knowledge
• Identify and implement process needs and improvement opportunities for moderate to high complexity issues
• Perform periodic reviews and reporting; collaborate across sites
• Update and manage area master data and recipes as needed
• Provide support on defined issues and contribute through application of expertise and knowledge
• Follow all safety and environmental requirements in the performance of duties
• Other duties as assigned

Qualifications

• Required: Bachelor’s degree (engineering, technology or related field) from an accredited university
• Preferred: Associate’s degree (engineering, technology or related field) in technology or related field with a minimum of four years of manufacturing experience, preferably in a pharmaceutical manufacturing environment
• Required: High School Diploma (GED) with a minimum of six years of manufacturing experience, preferably in a pharmaceutical manufacturing environment
• Required: Minimum of two years of manufacturing experience, preferably in a pharmaceutical manufacturing environment
• Required: 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 (e.g., SAP, PAS-X)
• Preferred: Demonstrated knowledge of adult learning methodologies and ability to train and coach others
• Required: General experience with regulatory audits/inspections
• Preferred: Knowledge of relevant master data
• Preferred: Validation experience
• Preferred: Product transfer (or tech transfer) experience

Skills

• Lean manufacturing
• Six Sigma methodologies
• Process knowledge and analytical skills
• Training and coaching (adult learning methodologies)
• Change control and Quality Management Systems (QMS)
• Experience with electronic manufacturing systems (e.g., SAP, PAS-X)
• Regulatory audits/inspections experience

Education

• Required: Bachelor’s degree in engineering, technology or related field from an accredited university
• Preferred: Associate’s degree in engineering, technology or related field
• Required: High School Diploma / GED

Additional Requirements

• Travel up to 20% of the time (may vary by role)
• Ability to work in an open office environment with the possibility of frequent distraction