Senior Process Engineer – GMP & Process Optimization

NCBiotech; Clayton (NC); On-site; USD 95,000 - 125,000; Full time

Benefits offered by this job

Health Insurance

Dental Insurance

Vision Insurance

8% 401K + company match

Paid holidays

Job summary

Novo Nordisk is seeking an experienced engineer for the Clayton, NC API site to support ongoing development of department processes and daily operations. The role includes ensuring system reliability, equipment qualification, and continuous improvement to meet customer, business, and regulatory requirements.

Responsibilities include driving process monitoring, collaborating across interfaces, coaching teammates, and ensuring knowledge transfer from other sites.

Qualifications

• Bachelor’s degree in Engineering, Science, or relevant field required.
• Associate's degree with 6 years GMP experience; high school diploma with 8 years GMP experience may be considered.
• Minimum 4 years of engineering or technical experience, GMP environment preferred.
• LEAN 1Star certification required.
• Knowledge of FDA/authorities' expectations preferred.
• Experience with process control systems preferred.
• Experience designing requirements documents preferred.
• Functional knowledge across track with operation expertise.
• Ability to support a 24/7 operation.

Responsibilities

• Support department processes and daily operations.
• Drive equipment qualification, optimization, validation and quality of equipment and processes.
• Coach and mentor team members.
• Lead process monitoring for key parameters and track initiatives.
• Collaborate with interfaces to other processes and support systems.
• Coordinate with site stakeholders.”
• Transfer knowledge from other Novo Nordisk production sites.
• Own personal development with manager and career path in mind.
• Generate improvement concepts and implement across track.
• Follow safety and environmental requirements.
• Perform other duties as assigned.

Skills

LEAN Certification

Cross-functional collaboration

Critical decision making

Education

Bachelor’s Degree in Engineering/Science

Associate’s Degree + 6 years GMP experience

High School Diploma + 8 years GMP experience

Tools

Process Control Systems

Requirements documents design

Job description

Novo Nordisk is seeking an experienced engineer for the Clayton, NC API site to support ongoing development of department processes and daily operations. The role includes ensuring system reliability, equipment qualification, and continuous improvement to meet customer, business, and regulatory requirements.

Responsibilities include driving process monitoring, collaborating across interfaces, coaching teammates, and ensuring knowledge transfer from other sites.