API Production Technician I

Novo Nordisk; Clayton (NC); Presencial; USD 30.000 - 47.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual bonus

Paid time off (14+ holidays)

Health insurance

Dental insurance

Vision insurance

401K with company match

Parental leave

Tuition assistance

Life & Disability Insurance

Employee referrals

Descripción de la vacante

Novo Nordisk in Clayton, NC seeks an API Manufacturing Operator to run and monitor highly automated production lines, ensuring strict GMP and cGMP compliance. You will manage batch records, execute the production schedule, and participate in qualification activities.

Strong problem-solving, SOP adherence, safety culture, and ability to read complex documentation are essential. The role includes comprehensive benefits, a safe work environment, and opportunities for career growth within Novo

Formación

• High school diploma or equivalent required.
• Associate's Degree or higher in Tech, Science, or Engineering preferred.
• BioWork or equivalent industrial/military/vocational training with experience preferred.
• Minimum two years of manufacturing experience in FDA-regulated environment preferred.
• Experience solving problems with data and facts; drive event response and rapid resolution.
• Experience following SOPs and raising issues when errors found.
• Experience following safety guidelines.
• Computer literacy and ability to operate manufacturing equipment; MS Office familiarity.
• Ability to read and understand complex product documentation and SOPs with attention to detail.
• Ability to perform basic material handling tasks and use handling equipment.
• Ensure compliance with SOPs, regulations, and ISO standards.
• General knowledge of cGMP manufacturing and production processes.
• Basic knowledge of biology/chemistry preferred.
• Mechanical aptitude and basic troubleshooting.
• Experience with work permits/Lock Out Tag Out systems preferred.

Responsabilidades

• Operate API manufacturing equipment to achieve production goals.
• Work in a safe and environmentally responsible manner.
• Follow GMP documentation and ensure product quality.
• Review SOPs and other documents as required.
• Real-time review of batch records for compliance with SOPs and cGMP.
• Manage individual training plans.
• Participate in qualification and validation activities as required.
• Set up, operate, monitor, and control highly automated processes and systems.
• Load and unload products from trucks and ISO containers as required.
• Execute production schedules to achieve goals.
• Apply investigation skills during troubleshooting and assist in equipment maintenance.
• Maintain cleanroom areas and perform environmental monitoring.
• Other accountabilities as assigned.

Conocimientos

Problem solving

SOPs adherence

Safety compliance

Reading complex docs

Material handling

CGMP knowledge

Biology/chemistry basics

Mechanical aptitude

Lock Out Tag Out

Educación

High school diploma or equivalent

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

Biowork or equivalent training

Descripción del empleo

Novo Nordisk in Clayton, NC seeks an API Manufacturing Operator to run and monitor highly automated production lines, ensuring strict GMP and cGMP compliance. You will manage batch records, execute the production schedule, and participate in qualification activities.

Strong problem-solving, SOP adherence, safety culture, and ability to read complex documentation are essential. The role includes comprehensive benefits, a safe work environment, and opportunities for career growth within Novo