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Process Engineer II - Fermentation

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 qualification & execution of the project phases for the Fermentation process, evolving into a process subject matter expert for the Fermentation area.

Main tasks include:

  • Support team in ensuring installed design adheres to process requirements
  • Coordinate & execute process validation activities
  • Provide technical support of the operating facility to meet business goals
  • Coach & mentor less experienced members of the process engineering team

 

 

Accountabilities

  • Overall validation responsible within area
  • Execute & coordinate all qualification activities included in the project (FAT, SAT, IQ, OQ, PQ)
  • Lead / provide technical support to investigation & resolution of VNC’s & NC’s
  • Support development & implementation of change requests during commissioning & operation
  • Verify process equipment & facilities satisfy design requirements. Ensure designs comply with current pharmaceutical standards applicable for the project such as ASME BPE, GAMP, cGMP, ISPE guidelines
  • Gathering & ensure knowledge transfer to project from DK sponsor site. Support or serve as Process Responsible in Process Groups
  • Support work packages in maintaining schedule & project milestone adherence
  • Ensure coordination & collaboration between project & other site stakeholders
  • Ensure design adheres with process FMECA's & resolve misalignments where observed
  • Develop knowledge of risk assessment documents such as requirements risk assessments (RRA's)
  • Support update, development & design adherence to requirement specification documents
  • Participation in review & update of QRM risk assessments such as closed-system, cross-contamination, contamination & facility flows
  • Apply Fermentation knowledge to the review & update of design documentation (process flow diagrams, P&IDs, etc.)
  • Provide design basis information for accurate process scheduling & capacity calculations
  • Other accountabilities, as assigned

 

Required Qualifications

  • BA/BS in chemical engineering, biological / biomedical engineering, or another pharmaceutical related field
  • 5-8 years engineering experience in operations, process design/troubleshooting/improvement

 

Desired Qualification

  • Six Sigma Green Belt certification or cLEAN® 2-star desired
  • Experience of working with Current Good Manufacturing Practices (cGMPs) & their applications
  • Demonstrated experience in Fermentation processes. Knowledgeable in the following systems: Instrument & Electrical, Mechanical, Control/SCADA/PLCs, Process Improvement Methodologies, Root Cause Analysis (RCA), Reliability Centered Maintenance (RCM)
  • Ability to independently apply advanced engineering techniques & analysis within the discipline
  • Strong project management skills
  • Excellent oral & written communication skills
  • Proven expertise in planning/organization/execution of maintenance activities & following up on results
  • Creating &/or 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
  • Routinely operates & inspects manufacturing equipment using hands
  • Must be able to be on feet for up to a 12-hour shift
  • Constantly positions oneself to transfer materials within manufacturing environment. Frequently moves about building(s) to access other personnel & operational areas
  • Corrected vision to 20/30 and/or ability to pass vision screening assessment necessary to procure motorized vehicle license
  • Occasionally ascends/descends a ladder to access service equipment. Works atop elevated positions at heights
  • Occasionally required to secure a motorized vehicle license & operate a motorized vehicle
  • Occasionally works around odorous and/or hazardous materials
  • Occasionally performs critical job functions in extremely cold work environments
  • Occasionally positions oneself within confined spaces for inspection, repair & maintenance of equipment
  • Able to work in loud noise environments with hearing protection
  • Able to travel internationally, up to 10% 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

 

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 II - Fermentation

Clayton, NC
Full Time

Published on 06/20/2020