Process Engineer II/III – Cleaning Validation
Novo Nordisk
full-time
Posted on:
Location Type: Office
Location: Clayton • North Carolina • United States
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About the role
- Support the ongoing development of the department processes.
- Support daily operations as well as 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.
- Support operations within the area through process knowledge sharing, critical decision making and strategy
- Drive equipment qualification & optimization, validation within area, quality of equipment & processes
- Coach & mentor team members
- Drive process monitoring activities for key process parameters and track initiatives
- Ensure identification of & collaboration regarding interfaces to other processes & support systems
- Ensure coordination & collaboration between site stakeholders
- Gather & ensure knowledge transfer to project from other similar production sites in Novo Nordisk
- Own self development and partner with manager for clear understanding of development needs for desired career path
- Generate improvement concepts, justify, & implement across track
- Follow all safety & environmental requirements in the performance of duties
- Other duties as assigned
Requirements
- Bachelor’s Degree in Engineering, Science, or relevant technical field of study from an accredited university required
- May consider an Associate’s Degree in Engineering, Science, or relevant technical field of study from an accredited university with six (6) years of relevant experience operating in a GMP regulated environment required, preferably in a GMP regulated environment
- May consider High School Diploma or equivalent with eight (8) years of relevant experience operating in a GMP regulated environment required, preferably in a GMP regulated environment
- Minimum four (4) years of engineering or technical experience required, preferably in a GMP regulated environment
- cLEAN 1Star Certified required
- Knowledge of requirements/expectations from authorities e.g. FDA preferred
- Proven ability to establish & maintain networks & facilitate processes that encourage cross organizational knowledge sharing preferred
- Experience with Process Control Systems preferred
- Experience with design of requirements documents preferred
- Functional knowledge across track with expertise in one or more operation required
- Ability to provide support for a 24/7 operational business required
Benefits
- Leading pay and annual performance bonus for all positions
- All employees enjoy generous paid time off including 14 paid holidays
- Health Insurance, Dental Insurance, 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
engineeringtechnical experienceprocess control systemsdesign of requirements documentsprocess monitoringequipment qualificationequipment optimizationtroubleshootingGMP regulationsquality assurance
Soft Skills
coachingmentoringcritical decision makingknowledge sharingcollaborationcommunicationnetworkingself-developmentstrategic thinkinginitiative tracking
Certifications
Bachelor’s DegreeAssociate’s DegreeHigh School DiplomacLEAN 1Star Certified