Recovery Process Engineer – GMP Manufacturing

BioSpace; Clayton (NC); On-site; USD 90,000 - 110,000; Full time

Benefits offered by this job

Paid holidays

Health & dental insurance

401K with company match

Tuition assistance

Life & disability insurance

Parental leave

Job summary

Novo Nordisk in Clayton, NC is seeking an engineer to provide routine support and troubleshooting for the manufacturing facility. Core duties include input, review and approval of design and requirement documents, plus technical specifications.

The role reports to a Manager or Senior Manager and supports design, risk assessments, and process diagrams to keep projects on track. Candidates should have an engineering or scientific degree, GMP experience preferred, and be prepared for a 24/7

Qualifications

• Bachelor’s degree in engineering, science or a relevant technical field.
• Associate’s degree with 2+ years engineering/technical experience in GMP preferred.
• High school diploma with 4+ years engineering/technical experience preferred.
• Minimum 1 year of engineering/technical experience, GMP preferred.
• Experience designing requirements documents is a plus.
• GMP experience is preferred.
• Familiarity with FDA or regulatory expectations is a plus.
• Experience with Process Control Systems is a plus.
• Proven ability to network and share knowledge across teams is a plus.
• Ability to support a 24/7 operation is required.

Responsibilities

• Support development of design and requirement specifications.
• Assist in quality of equipment and processes.
• Participate in risk assessments and QRM activities.
• Contribute to project cGMP documentation.
• Review Process FMEA and process diagrams.
• Coordinate cross-functional collaboration across site stakeholders.
• Support knowledge transfer from sponsor sites.
• Ensure compliance with safety and environmental requirements.

Education

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

Associate’s Degree in Engineering, Science, or relevant field

High School Diploma with 4+ years engineering/technical experience

1+ year engineering/technical experience in GMP environment

Experience with design of requirements documents

Experience in GMP regulated environment

Knowledge of regulatory authority expectations (FDA)

Experience with Process Control Systems

Networking and cross-functional collaboration

Ability to support 24/7 operations

Tools

Process Control Systems

Job description

Novo Nordisk in Clayton, NC is seeking an engineer to provide routine support and troubleshooting for the manufacturing facility. Core duties include input, review and approval of design and requirement documents, plus technical specifications.

The role reports to a Manager or Senior Manager and supports design, risk assessments, and process diagrams to keep projects on track. Candidates should have an engineering or scientific degree, GMP experience preferred, and be prepared for a 24/7