API Manufacturing Associate I (Night Shift)
Novo Nordisk
August 26, 2026
On-site
Clayton, NC
Operations
What We Offer You
- Leading pay and annual performance bonus for all positions
- Generous paid time off including 14 paid holidays
- Health, Dental, and Vision Insurance – effective day one
- Guaranteed 8% 401K contribution plus individual company match option
- Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
- Free access to Novo Nordisk-marketed pharmaceutical products
- Tuition Assistance
- Life & Disability Insurance
- Employee Referral Awards
The Position
- Operate API manufacturing equipment to achieve production goals.
Relationships
- Reports to Shift Manager, Operations – API.
Essential Functions
- Work in a safe and environmentally responsible manner.
- Follow GMP documentation/product quality requirements.
- Review SOPs and other documents as required.
- Perform real-time review of electronic batch records to ensure compliance with SOPs and cGMP.
- Manage individual training plan.
- Participate in qualification and validation activities as required.
- Setup, operate, monitor, and control highly automated processes and systems.
- Load/unload product from trucks, tankers, and ISO containers as required.
- Execute production schedule to achieve production goals.
- Troubleshoot using investigation skills; assist with equipment maintenance (restoring function; predictive/preventative maintenance).
- Maintain clean room areas and perform environmental monitoring as required.
Qualifications
- High school graduate or equivalent (required).
- Computer literacy; ability to operate computer-driven manufacturing/production equipment and efficiently use Microsoft Office (required).
- Ability to read/understand complex product documentation and SOPs with attention to detail (required).
- General knowledge in cGMP manufacturing/production processes associated with pharmaceutical companies (required).
- Ensure compliance with corporate/local SOPs, regulations, and ISO standards (required).
- Associate’s degree or higher in Tech, Science, or Engineering (preferred).
- BioWork or equivalent industrial/military/vocational training combined with experience (preferred).
- Minimum 2 years manufacturing experience in an FDA-regulated environment (preferred).
- Problem-solving/troubleshooting using data; participation in driven event response; documented prevention of recurrence (preferred).
- Experience following SOPs and raising issues when errors are found (preferred).
- Experience following established safety guidelines (preferred).
- Basic knowledge of biology/chemistry (preferred).
- Mechanical aptitude and basic troubleshooting of mechanical components/systems (preferred).
- Experience with work permits/Lock Out Tag Out systems (preferred).
- Leading pay and annual performance bonus for all positions
- Generous paid time off including 14 paid holidays
- Health, Dental, and Vision Insurance – effective day one
- Guaranteed 8% 401K contribution plus individual company match option
- Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
- Free access to Novo Nordisk-marketed pharmaceutical products
- Tuition Assistance
- Life & Disability Insurance
- Employee Referral Awards
The Position
- Operate API manufacturing equipment to achieve production goals.
Relationships
- Reports to Shift Manager, Operations – API.
Essential Functions
- Work in a safe and environmentally responsible manner.
- Follow GMP documentation/product quality requirements.
- Review SOPs and other documents as required.
- Perform real-time review of electronic batch records to ensure compliance with SOPs and cGMP.
- Manage individual training plan.
- Participate in qualification and validation activities as required.
- Setup, operate, monitor, and control highly automated processes and systems.
- Load/unload product from trucks, tankers, and ISO containers as required.
- Execute production schedule to achieve production goals.
- Troubleshoot using investigation skills; assist with equipment maintenance (restoring function; predictive/preventative maintenance).
- Maintain clean room areas and perform environmental monitoring as required.
Qualifications
- High school graduate or equivalent (required).
- Computer literacy; ability to operate computer-driven manufacturing/production equipment and efficiently use Microsoft Office (required).
- Ability to read/understand complex product documentation and SOPs with attention to detail (required).
- General knowledge in cGMP manufacturing/production processes associated with pharmaceutical companies (required).
- Ensure compliance with corporate/local SOPs, regulations, and ISO standards (required).
- Associate’s degree or higher in Tech, Science, or Engineering (preferred).
- BioWork or equivalent industrial/military/vocational training combined with experience (preferred).
- Minimum 2 years manufacturing experience in an FDA-regulated environment (preferred).
- Problem-solving/troubleshooting using data; participation in driven event response; documented prevention of recurrence (preferred).
- Experience following SOPs and raising issues when errors are found (preferred).
- Experience following established safety guidelines (preferred).
- Basic knowledge of biology/chemistry (preferred).
- Mechanical aptitude and basic troubleshooting of mechanical components/systems (preferred).
- Experience with work permits/Lock Out Tag Out systems (preferred).