API Production Technician I

BioSpace; Clayton (NC); On-site; USD 55,000 - 85,000; Full time

Benefits offered by this job

Performance bonus

Paid time off

Health insurance

401(k) with match

Parental leave

Tuition assistance

Life & disability insurance

Referral awards

Job summary

Novo Nordisk's API manufacturing facility in Clayton, NC is part of a global diabetes care leader. The role operates automated API production equipment, ensuring production goals while adhering to cGMP and SOPs.

The position reports to the Shift Manager, Operations – API and requires safety-minded, data-driven problem solving and teamwork. We offer competitive pay with annual performance bonus, comprehensive benefits from day one, 401(k) with company match, and generous PTO, parental leave,

Qualifications

• High school diploma or equivalent.
• Associate's Degree or higher in Tech, Science, or Engineering preferred.
• BioWork or equivalent industrial training with experience preferred.
• Minimum two years of manufacturing experience in FDA-regulated environment.
• Data-driven problem solving and active event response experience preferred.
• Follow SOPs and safety guidelines; read and apply SOPs accurately.
• Computer literacy; operate computer-driven equipment and MS Office.
• Read and interpret complex product documentation and SOPs.
• Basic material handling skills and use of handling equipment.
• Knowledge of cGMP and ISO standards.

Responsibilities

• Work in a safe and environmentally responsible manner.
• Follow GMP documentation and ensure product quality.
• Review SOPs and related documents as required.
• Real-time review of electronic batch records for cGMP compliance.
• Manage individual training plans.
• Participate in qualification and validation activities.
• Setup, operate, monitor, and control automated processes and systems.
• Load and unload product from trucks and ISO containers.
• Execute production schedules to meet goals.
• Support troubleshooting and equipment maintenance.
• Maintain cleanroom areas and conduct environmental monitoring.
• Other duties as assigned.

Skills

Manufacturing

GMP

SOPs

cGMP

Troubleshooting

Documentation

Safety

Computer literacy

Reading docs

Material handling

ISO standards

Biology/chemistry basics

Mechanical aptitude

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Education

Associate's Degree or higher in Tech/Science/Engineering

BioWork or equivalent training

High school diploma or equivalent

Tools

MS Office

Manufacturing control systems

Job description

Novo Nordisk's API manufacturing facility in Clayton, NC is part of a global diabetes care leader. The role operates automated API production equipment, ensuring production goals while adhering to cGMP and SOPs.

The position reports to the Shift Manager, Operations – API and requires safety-minded, data-driven problem solving and teamwork. We offer competitive pay with annual performance bonus, comprehensive benefits from day one, 401(k) with company match, and generous PTO, parental leave,