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Process Engineer III- Recovery

About the Department

At Novo Nordisk, we want to make a difference. For more than 95 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. Help us bring quality to life. Working at our Diabetes Active Pharmaceutical Ingredient (DAPI) manufacturing facility you will help meet the growing demand for our treatments. Novo Nordisk expects to double production of diabetes and obesity drugs over the next decade and are currently building a new 825,000 sq. ft diabetes Active Pharmaceutical Ingredient (API) plant in Clayton, NC next to our existing “fill and finish” manufacturing facility. Our new $2 billion API facility is expected to be operational in 2020, with 700 full-time employees responsible for the fermentation, recovery and purification of insulin and GLP1 ingredients. This once in a life-time career opportunity is ideal for pharmaceutical manufacturing professionals who not only understand the operational complexities of manufacturing but also have the desire and drive to help us build, validate, and run our processes. Here, you will work with the best manufacturing professionals in the industry. Are you ready to make a difference?

 

 

Position Purpose

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

 

 

Accountabilities

  • Overall validation responsible within area
  • Support development of design & requirement specifications documents
  • Ensure quality of equipment & processes
  • Creation of Recovery process risk assessment documents, such as Requirement Risk Assessments (RRA’s)
  • Participation in the creation of a project current Good Manufacturing Practice (cGMP) Statement
  • Creation & participation in QRM risk assessments, such as Closed-Process, Cross-Contamination, Contamination & Facility flows
  • Input & review to Process FMECA’s for Recovery
  • 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 engineering or related field. MA/MS/PhD preferred
  • Knowledgeable in the following systems: Instrument & Electrical, Mechanical, Control/SCADA/PLCs, Process Improvement Methodologies, Root Cause Analysis (RCA), Reliability Centered Maintenance (RCM)

 

Desired Qualifications

  • 8+ years engineering experience in maintenance, design, process improvement, cLEAN® 2 Star or Six Sigma Green Belt certification
  • 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 Requirements

  • Ability to work in & around an active construction site during project phase
  • Ability to move throughout the facility in the performance of duties in proximity to process equipment & areas
  • Ability to work hours necessary to support production & maintenance activities
  • Ability to travel locally & internationally as necessary
  • Ability to work in confined spaces & near operating equipment
  • Ability to work in noisy environments with hearing protection

 

At this time, Novo Nordisk is not currently hiring individuals for this position who now or in the future would require sponsorship for employment visa status

 

Novo Nordisk is an Equal Opportunity Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity.

 

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.

Process Engineer III- Recovery

Clayton, NC
Full Time

Published on 02/01/2020