Operations Area Specialist - FFEx - Aseptic Production

Novo Nordisk - Clayton, NC

Full-time - Mid Level

Clayton, NC

10,001+ employees

Merchant Wholesalers, Nondurable Goods

About the position

The Operations Area Specialist in Aseptic Production at Novo Nordisk is responsible for supporting operations areas to meet business and regulatory requirements. This role involves providing process solutions for routine to moderate complexity issues, supporting training for junior team members, and driving continuous improvements using Lean tools. The position is part of the Fill & Finish Expansions (FFEx) department, which focuses on designing and building new aseptic filling capacity to serve the needs of patients globally.

Responsibilities

• Support people, equipment, and processes for operations areas to meet business and regulatory requirements.
• Provide process solutions for routine to moderate complexity issues.
• Support training for junior team members.
• Work with production and QA to provide in-depth deviation investigations and root cause analysis.
• Drive continuous improvements via Lean tools.
• Provide training on process and procedure changes.
• Identify and implement process needs and improvement opportunities for routine to moderate complexity issues.
• Responsible for collection of data for periodic reviews and reporting.
• Follow all safety & environmental requirements in the performance of duties.

Requirements

• Bachelor's degree (engineering, technology or related field of study preferred) from an accredited university by May 2025 required.
• May consider an Associate's degree from an accredited university with a minimum of two (2) years of manufacturing experience required.
• May consider a High School Diploma (GED) with a minimum four (4) years of manufacturing experience required.
• Minimum of three (3) years of manufacturing experience preferred, preferably in a pharmaceutical manufacturing environment.
• Excellent written communication skills required.
• GMP knowledge required.
• Basic investigation and systematic problem-solving experience required.
• Manufacturing experience preferred.
• General knowledge of change control and Quality Management System (QMS) systems preferred.
• Relevant electronic manufacturing system experience preferred (ex: SAP, PAS-X, etc).
• Demonstrated knowledge of adult learning methodologies and ability to use multiple methods to train others preferred.
• Exposure to regulatory audits/inspections a plus.

Nice-to-haves

• Experience in pharmaceutical manufacturing environment.
• Knowledge of change control and Quality Management System (QMS) systems.
• Experience with electronic manufacturing systems like SAP or PAS-X.
• Knowledge of adult learning methodologies.

Benefits

• 401(k) 8% Match
• Paid holidays
• Disability insurance
• Health insurance
• Dental insurance
• Tuition reimbursement
• Paid time off
• Parental leave
• Vision insurance
• 401(k) matching