Associate Process Engineer (Onsite/Clayton, NC)

About the Department

At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world.

 

In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains.  Our newer Active Pharmaceutical Ingredients (API) facility in Clayton, NC sits on 825,000 square-feet of state-of-the-art equipment, and houses the Fermentation, Recovery and Purification in the production of ingredients for Novo Nordisk’s innovative oral products.  At API, you’ll join a global network of manufacturing professionals who are passionate about what they do.  

 

What we offer you:

• 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 12 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

 

At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career.  Are you ready to realize your potential?  Join Team Novo Nordisk and help us make what matters.
 

 

The Position

Ensure successful ramp-up of the process tracks. Process expert role in developing the project. Primary tasks:  provide input, review & approve design & requirement documents; provide input, review & approve technical specifications.

 

Relationships

Reports to Department Manager/Sr Manager.

 

Essential Functions

• Support development of design & requirement specifications documents
• Ensure quality of equipment & processes
• Support the creation of process tracks risk assessment documents, such as Requirement Risk Assessments (RRA’s)
• Participation in the creation of a project cGMP Statement
• Creation & participation in QRM risk assessments, such as Closed-Process, Cross-Contamination, Contamination & Facility flows
• Input & review to Process FMECA’s for the Process tracks
• Participation in design work shops with engineering suppliers
• Input & review of Process Module Diagrams, & Process Flow Diagrams
• Input & review of Process Scheduling & Capacity Calculations
• Support package in maintaining schedule adherence
• Ensure coordination & collaboration between project & other site stakeholders
• Gathering & ensure knowledge transfer to project from DK sponsor site
• Other duties or tasks, as assigned

 

Physical Requirements

Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Routinely operates & inspects manufacturing equipment using hands. Strap & unstrap pallets using hands. Must be able to be on your feet for up to a 12 hour shift. May require corrected vision to 20/20 or 20/25 based on role. May require col