API Manufacturing Associate I
Novo Nordisk
August 25, 2026
On-site
Clayton, NC
Operations
The Position
- Operate API manufacturing equipment to achieve production goals.
Essential Functions
- Work in a safe and environmentally responsible manner.
- Follow instructions in GMP documentation and product quality.
- Review SOPs and other documents as required.
- Perform real-time review of electronic batch records to ensure compliance with SOPs and current cGMP standards.
- Manage individual training plan.
- Participate in qualification and validation activities as required.
- Set up, operate, monitor, and control highly automated processes and systems.
- Load and unload product from trucks, tankers, and ISO containers as required.
- Execute the production schedule to achieve production goals.
- Use investigation skills during troubleshooting; assist with equipment maintenance including restoration of lost function and predictive/preventative maintenance.
- Maintain clean room areas and perform environmental monitoring as required.
- Other accountabilities as assigned.
Qualifications
- High school graduate 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 2 years manufacturing experience in an FDA-regulated environment (preferred).
- Problem-solving/troubleshooting using data and facts; participate in driven event response; document problems and ensure rapid resolution and prevention of recurrence (preferred).
- Experience following SOPs and raising issues if errors are found (preferred).
- Experience following established safety guidelines (preferred).
- Computer literacy to operate computer-driven equipment and use Microsoft Office (required).
- Ability to read and understand complicated product documentation/SOPs with attention to detail (required).
- Ability to perform basic material handling tasks and safely use material handling equipment (required).
- Ensure compliance with corporate/local SOPs, regulations, and ISO standards (required).
- General knowledge of cGMP manufacturing/production processes (required).
- Basic knowledge of biology/chemistry (preferred).
- Mechanical aptitude and basic troubleshooting of mechanical components/systems (preferred).
- Experience with work permits/Lock Out Tag Out (preferred).
What We Offer You (benefits)
- Leading pay and annual performance bonus.
- Paid time off including 14 paid holidays.
- Health, dental, and vision insurance effective day one.
- Guaranteed 8% 401(k) contribution plus individual company match option.
- 14 weeks paid parental and 6 weeks paid family medical leave.
- Free access to Novo Nordisk-marketed pharmaceutical products.
- Tuition Assistance.
- Life & Disability Insurance.
- Employee Referral Awards.
- Operate API manufacturing equipment to achieve production goals.
Essential Functions
- Work in a safe and environmentally responsible manner.
- Follow instructions in GMP documentation and product quality.
- Review SOPs and other documents as required.
- Perform real-time review of electronic batch records to ensure compliance with SOPs and current cGMP standards.
- Manage individual training plan.
- Participate in qualification and validation activities as required.
- Set up, operate, monitor, and control highly automated processes and systems.
- Load and unload product from trucks, tankers, and ISO containers as required.
- Execute the production schedule to achieve production goals.
- Use investigation skills during troubleshooting; assist with equipment maintenance including restoration of lost function and predictive/preventative maintenance.
- Maintain clean room areas and perform environmental monitoring as required.
- Other accountabilities as assigned.
Qualifications
- High school graduate 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 2 years manufacturing experience in an FDA-regulated environment (preferred).
- Problem-solving/troubleshooting using data and facts; participate in driven event response; document problems and ensure rapid resolution and prevention of recurrence (preferred).
- Experience following SOPs and raising issues if errors are found (preferred).
- Experience following established safety guidelines (preferred).
- Computer literacy to operate computer-driven equipment and use Microsoft Office (required).
- Ability to read and understand complicated product documentation/SOPs with attention to detail (required).
- Ability to perform basic material handling tasks and safely use material handling equipment (required).
- Ensure compliance with corporate/local SOPs, regulations, and ISO standards (required).
- General knowledge of cGMP manufacturing/production processes (required).
- Basic knowledge of biology/chemistry (preferred).
- Mechanical aptitude and basic troubleshooting of mechanical components/systems (preferred).
- Experience with work permits/Lock Out Tag Out (preferred).
What We Offer You (benefits)
- Leading pay and annual performance bonus.
- Paid time off including 14 paid holidays.
- Health, dental, and vision insurance effective day one.
- Guaranteed 8% 401(k) contribution plus individual company match option.
- 14 weeks paid parental and 6 weeks paid family medical leave.
- Free access to Novo Nordisk-marketed pharmaceutical products.
- Tuition Assistance.
- Life & Disability Insurance.
- Employee Referral Awards.