Process Engineer I - GMP Manufacturing & Optimization

BioSpace; Clayton (NC); On-site; USD 70,000 - 105,000; Full time

Job summary

Novo Nordisk in Clayton, NC seeks a Manufacturing Engineer to provide routine support and troubleshooting for the facility's core processes, improving system reliability and ensuring compliance with customer, business, and regulatory requirements.

The role requires collaboration with cross‑functional teams, participation in validation and verification activities, implementation of process improvements, and support for 24/7 operations.

Qualifications

• Bachelor’s Degree in Engineering, Science, or relevant technical field from an accredited university required with a minimum of one (1) year of engineering or technical experience required, preferably in a GMP regulated environment
• Associate’s Degree in Engineering, Science, or relevant technical field from an accredited university with a minimum of three (3) years of engineering or technical experience required, preferably in a GMP regulated environment
• High School Diploma or equivalent with a minimum of five (5) years of engineering or technical experience required, preferably in a GMP regulated environment
• Functional knowledge in assigned area required
• Ability to work in a team required
• Knowledge about requirements/expectations of regulatory authorities e.g. FDA a plus
• Experience with Process Control Systems a plus
• Proven ability to establish & maintain networks & facilitate processes that encourage cross organizational knowledge sharing a plus
• Ability to provide support for a 24/7 operational business required

Responsibilities

• Support validation & verification within area
• Ensure quality of equipment and processes
• Support process improvement project for assigned area
• Support manufacturing operations and provide technical support to the operating facilities to meet business goals
• Generate ideas & support implementation for improvement within area
• Own self development and partner with manager for clear understanding of development needs for desired career path
• Follow all safety & environmental requirements in the performance of duties
• Other duties as assigned

Skills

Engineering knowledge

Teamwork

Regulatory awareness

Education

Bachelor’s degree in Engineering/Science

Associate’s degree in Engineering/Science

High School Diploma

Tools

Process Control Systems

GMP environment experience

Job description

Novo Nordisk in Clayton, NC seeks a Manufacturing Engineer to provide routine support and troubleshooting for the facility's core processes, improving system reliability and ensuring compliance with customer, business, and regulatory requirements.

The role requires collaboration with cross‑functional teams, participation in validation and verification activities, implementation of process improvements, and support for 24/7 operations.