Process Engineer I - API

Facility:  Engineering
Location: 

Clayton, NC, US

About the Department

At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. For nearly 100 years, we have led the way in diabetes care. As a result, our employees embark on life-changing careers with opportunities for mobility and growth within a global organization. At Novo Nordisk, you will work with the best manufacturing professionals in the industry.

 

Our new Active Pharmaceutical Ingredients (API) facility houses the Fermentation, Recovery and Purification in the production of ingredients for Novo Nordisk’s innovative oral products. Are you ready to help make what matters? Then, we are ready for you!

 

Position Purpose

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.

 

Accountabilities

  • 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

 

Required Qualifications

BA/BS in Science or Engineering (preferably Mechanical, Electrical, Chemical or Industrial), or an equivalent combination of education & related experience in a GMP environment for more than five (5) years.

 

Desired Qualifications

  • Minimum of one (1) year of work-related engineering experience in Manufacturing, Design, Maintenance or Process Improvement
  • Knowledgeable in the following systems:  Instrument & Electrical, Mechanical, Control/SCADA/PLCs, Process Improvement Methodologies, Root Cause Analysis (RCA), Reliability Centered Maintenance (RCM)
  • Proven expertise in planning/organization/execution of maintenance activities, following up on results & revising the work plan for complex problems being resolved by cross functional teams

 

Physical & Other Requirements

  • Occasionally moves equipment and/or supplies weighing up to 50 pounds within the facility using various body positions
  • Routinely operates & inspects manufacturing equipment using hands
  • Ability to be on feet for up to a 12-hour shift
  • Corrected vision to 20/30
  • Occasionally ascends/descends a ladder to service equipment & can work atop elevated positions
  • Occasionally works around odorous and/or hazardous materials
  • May be required to wear latex gloves
  • Able to work in loud noise environments with hearing protection
  • Able to work for short periods of time with respiratory protection
  • Able to travel internationally, up to 25% of the time
  • Able to work in an open office environment with the possibility of frequent distraction
  • Able to work the hours necessary to support a 24/7 continuous manufacturing operation

 

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

 

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

 

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

 

Novo Nordisk requires all new hires to be fully vaccinated against COVID-19 prior to the first date of employment. As required by applicable law, Novo Nordisk will consider requests for reasonable accommodation.

 

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.