GMP Manufacturing Process Engineer – Design & Quality Support

Novo Nordisk; Clayton (NC); Presencial; USD 70 000 - 110 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Annual bonus

Paid time off

Health insurance

401K with company match

Parental leave

Tuition assistance

Life & disability insurance

Referral program

Resumo da oferta

Novo Nordisk in North Carolina's Clayton API facility seeks a technical professional to provide routine support and troubleshooting for the manufacturing facility. You will input, review, and approve design and requirement documents and technical specifications, while promoting quality and regulatory compliance.

The role emphasizes collaboration across engineering, project teams, and site stakeholders, with a focus on process quality, safety, and continuous development in a GMP environment.

Qualificações

• Bachelor’s degree in Engineering, Science, or relevant technical field required.
• Minimum 1 year engineering/technical experience preferred, GMP setting a plus.
• Experience with design of requirements documents is a plus.
• Familiarity with regulatory expectations (FDA) is beneficial.

Responsabilidades

• Support development of design and requirement specifications documents.
• Support quality of equipment and processes.
• Participate in Process FMECA reviews for the Process tracks.
• Create and participate in Quality Risk Management (QRM) activities.
• Coordinate with project and site stakeholders to ensure timely delivery.
• Follow safety and environmental requirements in performance of duties.

Conhecimentos

Design specs

Risk assessment

Cross-functional collab

GMP knowledge

Formação académica

B.S. in Engineering

A.S. in Engineering

HS Diploma + 4y exp

Ferramentas

Process Control Systems

cGMP documentation tools

Descrição da oferta de emprego

Novo Nordisk in North Carolina's Clayton API facility seeks a technical professional to provide routine support and troubleshooting for the manufacturing facility. You will input, review, and approve design and requirement documents and technical specifications, while promoting quality and regulatory compliance.

The role emphasizes collaboration across engineering, project teams, and site stakeholders, with a focus on process quality, safety, and continuous development in a GMP environment.