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Associate Process Engineer - API

Company: Novo Nordisk
Location: Clayton
Posted on: March 20, 2023

Job Description:

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. 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.
In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our newer Active Pharmaceutical Ingredients (API) facility in Clayton, NC sits on 825,000 square-feet of state-of-the-art equipment, and houses the Fermentation, Recovery and Purification in the production of ingredients for Novo Nordisk's innovative oral products. At API, you'll join a global network of manufacturing professionals who are passionate about what they do.
What we offer you:

  • Leading pay and annual performance bonus for all positions

  • All employees enjoy generous paid time off including 14 paid holidays

  • Health Insurance, Dental Insurance, Vision Insurance - effective day one

  • Guaranteed 8% 401K contribution plus individual company match option

  • Family Focused Benefits including 12 weeks paid parental & 6 weeks paid family medical leave

  • Free access to Novo Nordisk-marketed pharmaceutical products

  • Tuition Assistance - reimbursement up to $10,000 annually

  • Life & Disability Insurance

  • Employee Referral Awards

    At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.
    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.

    • 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.

Keywords: Novo Nordisk, Raleigh , Associate Process Engineer - API, Engineering , Clayton, North Carolina

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