Associate Process Engineer - API
Novo Nordisk
4 hours ago
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, 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
The Position:
- Provide routine support and troubleshooting for the manufacturing facility.
- Provide input, review, and approve design/requirement documents and technical specifications.
Essential Functions:
- Support design and requirement specifications; support quality of equipment and processes
- Create process track risk assessment documents (e.g., Requirement Risk Assessments)
- Participate in creation of project cGMP Statement
- Create/participate in QRM risk assessments (e.g., Closed-Process, Cross-Contamination, Contamination & Facility flows)
- Own self-development with manager for career path needs
- Input/review Process FMECA’s for process tracks
- Participate in design workshops with engineering suppliers
- Input/review Process Module Diagrams, Process Flow Diagrams, Process Scheduling & Capacity Calculations
- Support schedule adherence and coordinate with project/site stakeholders
- Gather/ensure knowledge transfer from DK sponsor site
- Follow safety and environmental requirements; other duties as assigned
Qualifications:
- Bachelor’s degree in Engineering/Science/relevant technical field (required); or anticipated by 6/30/26 or within 12 months
- May consider Associate’s with 2+ years engineering/technical experience (preferably GMP)
- May consider High School + 4 years engineering/technical experience (preferably GMP)
- Preferred: 1+ year engineering/technical experience (preferably GMP)
- Plus: design of requirements documents; GMP experience; regulatory expectations knowledge (e.g., FDA); Process Control Systems; cross-organizational knowledge sharing; 24/7 operational support required
- Leading pay and annual performance bonus for all positions
- Generous paid time off including 14 paid holidays
- Health, Dental, 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
The Position:
- Provide routine support and troubleshooting for the manufacturing facility.
- Provide input, review, and approve design/requirement documents and technical specifications.
Essential Functions:
- Support design and requirement specifications; support quality of equipment and processes
- Create process track risk assessment documents (e.g., Requirement Risk Assessments)
- Participate in creation of project cGMP Statement
- Create/participate in QRM risk assessments (e.g., Closed-Process, Cross-Contamination, Contamination & Facility flows)
- Own self-development with manager for career path needs
- Input/review Process FMECA’s for process tracks
- Participate in design workshops with engineering suppliers
- Input/review Process Module Diagrams, Process Flow Diagrams, Process Scheduling & Capacity Calculations
- Support schedule adherence and coordinate with project/site stakeholders
- Gather/ensure knowledge transfer from DK sponsor site
- Follow safety and environmental requirements; other duties as assigned
Qualifications:
- Bachelor’s degree in Engineering/Science/relevant technical field (required); or anticipated by 6/30/26 or within 12 months
- May consider Associate’s with 2+ years engineering/technical experience (preferably GMP)
- May consider High School + 4 years engineering/technical experience (preferably GMP)
- Preferred: 1+ year engineering/technical experience (preferably GMP)
- Plus: design of requirements documents; GMP experience; regulatory expectations knowledge (e.g., FDA); Process Control Systems; cross-organizational knowledge sharing; 24/7 operational support required