Process Specialist I — GMP & Lean Improvements

Novo Nordisk A/S; Powhatan (NC); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Health Insurance

Dental Insurance

Vision Insurance

401K with company match

Parental Leave (14 weeks)

Family Medical Leave (6 weeks)

Product Access ( Novo Nordisk products

Life Insurance

Disability Insurance

Paid Holidays

Job summary

Novo Nordisk is seeking a Process Professional I for the DPM Expansions - FP Packaging on the Day Shift in Clayton, NC. This role supports operations, investigates deviations, and drives continuous improvement with Lean tools, GMP-compliant practices, and training for junior staff.

Join FFEx, a growing team responsible for aseptic filling capacity, QA collaboration, and regulatory readiness, with strong growth, health benefits from day one, and a comprehensive benefits package.

Qualifications

• Bachelor’s degree (engineering, technology or related field) from an accredited university 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 one (1) year of manufacturing experience preferred, preferably in a pharmaceutical manufacturing environment.
• 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.
• Demonstrated knowledge of adult learning methodologies and ability to use multiple methods to train others preferred.
• Exposure to regulatory audits/inspections a plus.

Responsibilities

• 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.
• Other accountabilities, as assigned.

Skills

GMP knowledge

Problem-solving

Training others

Lean tools

Data collection & reporting

Regulatory audits exposure

Education

Bachelor’s degree (engineering, technology or related field)

Associate’s degree (2+ years manufacturing)

High School Diploma (GED) (4+ years manufacturing)

Job description

Novo Nordisk is seeking a Process Professional I for the DPM Expansions - FP Packaging on the Day Shift in Clayton, NC. This role supports operations, investigates deviations, and drives continuous improvement with Lean tools, GMP-compliant practices, and training for junior staff.

Join FFEx, a growing team responsible for aseptic filling capacity, QA collaboration, and regulatory readiness, with strong growth, health benefits from day one, and a comprehensive benefits package.