Manager, Technical Support - RMS & ETOH

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

Provide technical support & subject matter expertise to Raw Materials & Solvents Operations & Ethanol Production. Support Utilities, Raw Materials & Solvents Operations & API Production in ensuring all systems under responsibility are available to supply customers. Establish & maintain good communication & working relationship with stakeholders. Meet or exceed customer, business & regulatory requirements in accordance with Novo Nordisk Way. Ensure all activities are aligned with EHS program.

 

Accountabilities

  • Lead RMS & Ethanol Team owning all systems & equipment
  • Manage & manipulate computer systems in operation of RMS/Etoh. MES, Delta V, SAP. PI, SOPs/Standards
  • Manage Internal & external stakeholders including maintenance, supply chain, production tracks
  • Manage all quality systems for ownership areas including, change control, deviations, & validation requirements
  • Manage batch documentation in logbooks
  • Owns area GHK
  • Responsible for Performance reviews & developmental planning
  • Responsible for Budget adherence
  • Responsible for all safety & environmental requirements for system areas
  • Responsible for technical documentation related to equipment (URS, P&ID, SARR, COMR, etc.)
  • Responsible for continuous process improvement using cLEAN® tools such as SPS & Process Confirmation
  • Responsible for technical training & development for Production & Reliability
  • Drive Improvement projects & Investment Projects for area of ownership
  • Ensure the use of Good Engineering Practice & modularization
  • Ensure safety of high hazard chemicals
  • Technical expertise in RMS & Ethanol supporting site production
  • Coordinating resources to meet production demands
  • Coordinating Preventative & Conditional Maintenance ensuring equipment uptime
  • Ensure Engineering Interface with Production & Maintenance
  • Collaboration within NN to gain best practices & equipment specifications
  • Other accountabilities, as assigned

 

Required Qualifications

BA/BS in mechanical, electrical, or chemical engineering, or an equivalent combination of education & experience.

 

Desired Qualifications

  • Minimum of seven (7) years of engineering & management experience in support of a pharmaceutical manufacturing facility
  • Knowledge & experience in the operations, maintenance & design of cGMP utilities, as well as working in a regulated environment (FDA, cGMP, OSHA)
  • Thorough knowledge of RMS systems
  • Knowledgeable in API production & integration points
  • Ability to read/review design drawings (CAD) with an understanding of P&ID
  • Thorough understanding of technical documents such as URS, SAT, FAT, COMR, RTM & Validation Protocols
  • Thorough understanding of standard operating procedures with attention to high-level concepts
  • Knowledgeable in safety hazards & requirements
  • High level understanding of automation & computer systems including MES, SAP, Delta V
  • Proven expertise in mentoring/development, planning/organizing, managing execution & revising the work plan for complex problems solved by cross functional teams

 

Physical & Other Requirements

  • Occasionally moves equipment &/or supplies weighing up to 33 pounds within the facility
  • Routinely operates & inspects manufacturing equipment using hands.  Ability to be on feet for up to a 12-hour shift
  • Constantly positions self to transfer materials within manufacturing environment
  • Frequently moves about the building to access other personnel & operational areas
  • Corrected vision to 20/30 &/or ability to pass vision screening assessment necessary to procurement motorized vehicle license
  • Occasionally ascends/descends a ladder to service equipment. Works atop elevated positions at heights
  • Occasionally required to secure a motorized vehicle license & operate a motorized vehicle
  • Occasionally works around odorous &/or hazardous materials
  • Occasionally performs critical job functions in extremely cold work environments
  • Occasionally positions self within confined spaces for inspection, repair & maintenance of equipment
  • Ability to work in loud noise environments with hearing protection
  • Ability to travel domestically & internationally, as required
  • Ability to work in an open office environment with the possibility of frequent distraction
  • Ability to work the hours necessary to support a 24/7 continuous manufacturing operation
  • Ability to adjust schedule to work with colleagues in other international time zones

 

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.