API Manufacturing Associate I (Night Shift)
Novo Nordisk
4 months ago
On-site
Clayton, NC
Operations
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 and product quality requirements.
- Review SOPs and other documents as required.
- 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 (restoration of lost function, predictive and preventative maintenance).
- Maintain clean room areas and perform environmental monitoring as required.
- Other accountabilities as assigned.
Physical Requirements (selected)
- Move equipment/supplies up to 33 pounds; be on your feet up to a 12-hour shift.
Qualifications
- High school graduate or equivalent (required).
- Associate’s degree or higher in Tech/Science/Engineering (preferred).
- BioWork or equivalent industrial/military/vocational training plus experience (preferred).
- Minimum 2 years manufacturing experience in an FDA-regulated environment (preferred).
- Systematic problem-solving/troubleshooting based on data; participate in/drive event response; document problems and prevent recurrence (preferred).
- Experience following SOPs and raising issues when errors are found (preferred).
- Experience following established safety guidelines (preferred).
- Computer literacy to operate computer-driven manufacturing/production equipment and use Microsoft Office (required).
- Ability to read/understand complicated product documentation and SOPs with attention to detail (required).
- Ability to perform basic material handling tasks and use material handling equipment (required).
- Ensure compliance with corporate/local SOPs, regulations, and ISO standards (required).
- General knowledge of cGMP manufacturing/production processes for pharmaceutical companies (required).
- Basic biology/chemistry knowledge (preferred).
- Mechanical aptitude; follow tools and perform basic mechanical troubleshooting (preferred).
- Experience with work permits/Lock Out Tag Out (preferred).
Benefits
- Leading pay and annual performance bonus.
- 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: 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.
Application instructions
- If you need special assistance or an accommodation to apply, call 1-855-411-5290 (accommodation requests only).
- 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 and product quality requirements.
- Review SOPs and other documents as required.
- 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 (restoration of lost function, predictive and preventative maintenance).
- Maintain clean room areas and perform environmental monitoring as required.
- Other accountabilities as assigned.
Physical Requirements (selected)
- Move equipment/supplies up to 33 pounds; be on your feet up to a 12-hour shift.
Qualifications
- High school graduate or equivalent (required).
- Associate’s degree or higher in Tech/Science/Engineering (preferred).
- BioWork or equivalent industrial/military/vocational training plus experience (preferred).
- Minimum 2 years manufacturing experience in an FDA-regulated environment (preferred).
- Systematic problem-solving/troubleshooting based on data; participate in/drive event response; document problems and prevent recurrence (preferred).
- Experience following SOPs and raising issues when errors are found (preferred).
- Experience following established safety guidelines (preferred).
- Computer literacy to operate computer-driven manufacturing/production equipment and use Microsoft Office (required).
- Ability to read/understand complicated product documentation and SOPs with attention to detail (required).
- Ability to perform basic material handling tasks and use material handling equipment (required).
- Ensure compliance with corporate/local SOPs, regulations, and ISO standards (required).
- General knowledge of cGMP manufacturing/production processes for pharmaceutical companies (required).
- Basic biology/chemistry knowledge (preferred).
- Mechanical aptitude; follow tools and perform basic mechanical troubleshooting (preferred).
- Experience with work permits/Lock Out Tag Out (preferred).
Benefits
- Leading pay and annual performance bonus.
- 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: 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.
Application instructions
- If you need special assistance or an accommodation to apply, call 1-855-411-5290 (accommodation requests only).