Process Engineer II/III - Cleaning Validation
Novo Nordisk
5 hours ago
On-site
Clayton, NC
Operations
The Position
Support the ongoing development of the department processes. Support daily operations and continuous improvement of department processes, including ensuring system & equipment reliability to meet customer, business, and regulatory requirements. Provide routine support and troubleshooting for the manufacturing facility.
Essential Functions
- Support operations through process knowledge sharing, critical decision making, and strategy
- Drive equipment qualification & optimization and validation within area for quality of equipment/processes
- Coach & mentor team members
- Drive process monitoring for key process parameters and track initiatives
- Ensure identification of and collaboration on interfaces to other processes/support systems
- Coordinate & collaborate between site stakeholders
- Gather and ensure knowledge transfer to projects from similar Novo Nordisk production sites
- Own self-development and partner with manager on development needs for desired career path
- Generate, justify, and implement improvement concepts
- Follow all safety & environmental requirements
- Other duties as assigned
Relationships
Reports to Manager & Senior Manager.
Qualifications
- Bachelor’s Degree in Engineering, Science, or relevant technical field (required)
- Associate’s degree with 6 years relevant GMP experience, or High School Diploma/equivalent with 8 years relevant GMP experience (required)
- Minimum 4 years engineering/technical experience (preferably in GMP)
- cLEAN 1Star Certified (required)
- Authority requirements knowledge (e.g., FDA) (preferred)
- Cross-organizational knowledge sharing network facilitation (preferred)
- Process Control Systems (preferred)
- Design of requirements documents (preferred)
- Functional knowledge across track; expertise in one or more operation (required)
- Ability to support a 24/7 operational business (required)
Benefits (What We Offer You)
- Leading pay and annual performance bonus
- Paid time off including 14 paid holidays; health/dental/vision effective day one
- Guaranteed 8% 401K contribution plus individual company match option
- 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
Support the ongoing development of the department processes. Support daily operations and continuous improvement of department processes, including ensuring system & equipment reliability to meet customer, business, and regulatory requirements. Provide routine support and troubleshooting for the manufacturing facility.
Essential Functions
- Support operations through process knowledge sharing, critical decision making, and strategy
- Drive equipment qualification & optimization and validation within area for quality of equipment/processes
- Coach & mentor team members
- Drive process monitoring for key process parameters and track initiatives
- Ensure identification of and collaboration on interfaces to other processes/support systems
- Coordinate & collaborate between site stakeholders
- Gather and ensure knowledge transfer to projects from similar Novo Nordisk production sites
- Own self-development and partner with manager on development needs for desired career path
- Generate, justify, and implement improvement concepts
- Follow all safety & environmental requirements
- Other duties as assigned
Relationships
Reports to Manager & Senior Manager.
Qualifications
- Bachelor’s Degree in Engineering, Science, or relevant technical field (required)
- Associate’s degree with 6 years relevant GMP experience, or High School Diploma/equivalent with 8 years relevant GMP experience (required)
- Minimum 4 years engineering/technical experience (preferably in GMP)
- cLEAN 1Star Certified (required)
- Authority requirements knowledge (e.g., FDA) (preferred)
- Cross-organizational knowledge sharing network facilitation (preferred)
- Process Control Systems (preferred)
- Design of requirements documents (preferred)
- Functional knowledge across track; expertise in one or more operation (required)
- Ability to support a 24/7 operational business (required)
Benefits (What We Offer You)
- Leading pay and annual performance bonus
- Paid time off including 14 paid holidays; health/dental/vision effective day one
- Guaranteed 8% 401K contribution plus individual company match option
- 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