API Manufacturing Associate I: Automation & Cleanroom Ops

Novo Nordisk A/S; Clayton (NC); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

14 paid holidays

Health Insurance

Dental Insurance

Vision Insurance

401K with company match

Job summary

Novo Nordisk is seeking a dedicated professional to operate API manufacturing equipment and help fulfill production goals at our Clayton, NC site. The role emphasizes safety, procedural accuracy, and compliance with GMP/cGMP standards in a highly automated environment.

You will review SOPs, participate in qualification and validation activities, and ensure proper training and documentation. A high school diploma is required, with preferred associates in tech/science or BioWork training.

Qualifications

• Minimum two years of manufacturing experience in FDA-regulated environment preferred.
• Experience following SOPs to perform tasks and raising issues if errors are found preferred.
• Experience following established safety guidelines when performing tasks preferred.
• Ability to read and understand complicated product documentation and SOPs with attention to detail required.

Responsibilities

• Operate API manufacturing equipment to achieve production goals.
• Work in a safe and environmentally responsible manner.
• Follow GMP documentation and product quality requirements.
• Review SOPs and other documents as required.
• Real-time review of electronic batch records to ensure compliance with SOPs and cGMP standards.
• Manage individual training plans and participate in qualification and validation activities.
• Set up, operate, monitor, and control highly automated processes and systems.
• Load and unload product from trucks, tanks, ISO containers as required.
• Execute production schedule to achieve production goals.
• Assist with equipment maintenance, including restoration of lost function and preventative maintenance.
• Maintain clean room areas and perform environmental monitoring as required.

Skills

Manufacturing experience

SOP adherence

Mechanical aptitude

Microsoft Office

Reading technical docs

Education

High school diploma

Associate degree or higher in tech/science/engineering

BioWork or equivalent training

Tools

Microsoft Office

Job description

Novo Nordisk is seeking a dedicated professional to operate API manufacturing equipment and help fulfill production goals at our Clayton, NC site. The role emphasizes safety, procedural accuracy, and compliance with GMP/cGMP standards in a highly automated environment.

You will review SOPs, participate in qualification and validation activities, and ensure proper training and documentation. A high school diploma is required, with preferred associates in tech/science or BioWork training.