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Associate Process Engineer - API

Facility:  Engineering
Location: 

Clayton, NC, US

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 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

 

No relocation is available for this role.

 

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.