API Manufacturing Operator I – Pharma Production

BioSpace; Clayton (NC); On-site; USD 48,000 - 70,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401K with company match

Parental & family leave

Paid holidays

Tuition assistance

Life & disability insurance

Employee referral awards

Access to Novo Nordisk products

Job summary

Novo Nordisk operates an advanced API manufacturing facility in Clayton, NC. The role focuses on operating highly automated production equipment to meet strict quality and safety standards in an FDA-regulated environment.

You will follow SOPs, participate in qualification/validation activities, and ensure real-time batch record accuracy while supporting training and safe operation of equipment.

Qualifications

• High school graduate or equivalent; technical degree preferred.
• Associate degree or higher in tech, science, or engineering preferred.
• BioWork or equivalent industrial training plus experience preferred.
• Minimum two years of manufacturing experience in FDA-regulated environment preferred.
• Ability to read and follow SOPs with attention to detail.
• Experience with cGMP and ISO standards in pharmaceutical production preferred.

Responsibilities

• Operate API manufacturing equipment to achieve production goals.
• Follow GMP documentation and product quality requirements.
• Review SOPs and other documents as required.
• Conduct real-time review of electronic batch records for compliance.
• Assist with training plans and qualification/validation activities.
• Set up, operate, monitor, and control highly automated processes and systems.
• Load and unload products from trucks and ISO containers as required.
• Execute production schedule to meet goals.
• Assist with maintenance and troubleshooting, including preventive measures.
• Maintain clean rooms and environmental monitoring as required.

Skills

GMP awareness

SOP literacy

Manufacturing equipment operation

Problem solving

Safety training

Computer literacy

Education

Associate's Degree in Tech/Science/Engineering

BioWork or equivalent training

High school diploma

Tools

Microsoft Office

Manufacturing software

Equipment control systems

Job description

Novo Nordisk operates an advanced API manufacturing facility in Clayton, NC. The role focuses on operating highly automated production equipment to meet strict quality and safety standards in an FDA-regulated environment.

You will follow SOPs, participate in qualification/validation activities, and ensure real-time batch record accuracy while supporting training and safe operation of equipment.