Process Specialist

The Position

• Provide process, technical, and strategic support as the Site Subject Matter Expert (SME) for the department.
• Lead and support various projects based on evolving business needs.
• Coach/mentor Process Professionals.
• Communicate with vendors and engineering firms regarding projects and technical issues.
• Complete assigned projects/tasks within cost, quality, and schedule requirements.
• Present project status updates to Senior Management.

• Support senior leadership in strategic discussions and decision making.
• Own area content and process knowledge; perform periodic reviews, validation processes, and reporting.
• Drive continuous improvement, productivity, and cost reduction through technical expertise.
• Provide technical oversight for deviations, root cause analysis, validation, and process changes/improvements.
• Evaluate process/maintenance data; guide continuous improvements using Lean and Six Sigma.
• Serve as technical expert to auditors/inspectors.
• Share best practices across departments and NN sites; support other areas with process knowledge.
• Identify and implement process needs and improvement opportunities; support achievement of department goals.
• Lead guidance for complex maintenance matters.
• Communicate production/industry trends to drive cGMP.
• Implement new process/maintenance technologies and coordinate changes per regulatory procedures.
• Follow all safety and environmental requirements.

• Bachelor’s degree (engineering/technology/related) + 8+ years manufacturing experience (preferably pharma).
• OR Associate’s + 10+ years; OR High School/GED + 12+ years.
• Thorough systematic problem-solving; LEAN experience/training.
• Strong written, investigative, and computer skills.
• Ability to read/understand complex product documentation and SOPs.
• Continuous improvement via Lean/Six Sigma; proven planning/organizing and execution.
• Knowledge of change control and QMS; validation knowledge (product/tech transfer preferred).
• Regulatory audit/inspection experience.
• Knowledge of electronic manufacturing systems/master data (e.g., SAP, PAS-X).
• Adult learning/ability to train and coach.

• Leading pay and annual performance bonus; generous PTO incl. 14 paid holidays.
• Health, dental, vision insurance (effective day one); 8% 401(k) contribution + company match option.
• 14 weeks paid parental leave; 6 weeks paid family medical leave.
• Free access to Novo Nordisk–marketed pharmaceutical products; tuition assistance; life & disability insurance; employee referral awards.