Process Engineer II: GMP Operations & Optimization

Novo Nordisk; Clayton (NC); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Paid time off

Health Insurance (medical, dental, and

401K with company match

Parental & family medical leave

Tuition Assistance

Life & Disability Insurance

Employee referral program

Job summary

Novo Nordisk is seeking a versatile engineer to support API production processes at our Clayton, NC facility. You will contribute to process qualification, equipment optimization, and cross-functional collaboration to ensure GMP-compliant operations and continuous improvement.

The role requires a strong engineering background, experience in GMP environments, and leadership to coach teammates while maintaining safety and regulatory standards.

Qualifications

• Bachelor’s Degree in Engineering, Science, or relevant technical field from an accredited university required.
• Associate’s Degree in Engineering, Science, or relevant technical field from an accredited university with six (6) years of relevant experience operating in a GMP regulated environment required.
• High School Diploma or equivalent with eight (8) years of relevant experience operating in a GMP regulated environment required.

Responsibilities

• Support operations within the area through process knowledge sharing, critical decision making and strategy
• Drive equipment qualification & optimization, validation within area, quality of equipment & processes
• Coach & mentor team members
• Drive process monitoring activities for key process parameters and track initiatives
• Ensure identification of & collaboration regarding interfaces to other processes & support systems
• Ensure coordination & collaboration between site stakeholders
• Gather & ensure knowledge transfer to project from other similar production sites in Novo Nordisk
• Own self development and partner with manager for clear understanding of development needs for desired career path
• Generate improvement concepts, justify, & implement across track
• Follow all safety & environmental requirements in the performance of duties
• Other duties as assigned

Skills

Lean 1Star Certified

Process Control Systems

Design of Requirements Documents

Cross-functional collaboration

Safety & Environmental Compliance

Education

Bachelor’s Degree in Engineering, Science, or relevant technical field

Associate’s Degree in Engineering, Science, or relevant technical field (6+ years GMP)

High School Diploma or equivalent (8+ years GMP)

Job description

Novo Nordisk is seeking a versatile engineer to support API production processes at our Clayton, NC facility. You will contribute to process qualification, equipment optimization, and cross-functional collaboration to ensure GMP-compliant operations and continuous improvement.

The role requires a strong engineering background, experience in GMP environments, and leadership to coach teammates while maintaining safety and regulatory standards.