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Project Manager I/II - IT & Automation API

Employer
Novo Nordisk
Location
Clayton, NC
Start date
Jan 23, 2025
View more categoriesView less categories
Discipline
Engineering, Automation Engineer
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Bio NC, Best Places to Work

Job Details

About the Department

At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. For more than 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 14 weeks paid parental & 6 weeks paid family medical leave
  • Free access to Novo Nordisk-marketed pharmaceutical products
  • Tuition Assistance 
  • 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.
 

 

The Position

Primary responsibility is to provide project management services for new IT & Automation projects & processes. Scope of projects includes computer systems, facility, utility, equipment & processes associated with the production of API.  Assist in managing the IT Automation roadmap (project portfolio).

 

Relationships

Coached by: Senior Manager, IT & Automation – API.

 

Essential Functions

  • Refine business case with project owner/sponsor
  • Establish & communicate quantifiable project benefits
  • Refine & clarify project scope through early project analysis with subject matter experts & owners to further substantiate project purpose
  • Provide clear goals so the project secures effective use of time & resources & builds employee motivation
  • Develop time/resource estimates to complete projects
  • Develop bid packages, bid evaluation & drive vendor selection. Also work with procurement to create project specific contracts
  • Responsible for financial project accountability through purchase order creation, management, invoicing & cost forecasting
  • Monitor & control project work with stringent follow-up on quality, schedule & budget so the project delivers the desired end-product
  • Manage, coordinate & direct contract/internal resources
  • Ensure the right amount of resources & competences is allocated to the project & negotiate project resources with line of business (LoB) management
  • Report project performance to the relevant stakeholders
  • Manage strategy development & implementation of change control, qualification & validation for project
  • Archive all key project & test documentation in compliance with good documentation practices
  • Ensure alignment with global programs & other site projects to actively share best practice, knowledge & visions
  • Leads project activities associated with projects of all sizes
  • Creates master plans for projects that outline all required activities associated with the projects
  • Develop timelines & resource estimates to complete projects. Requires no guidance & direction to complete these goals & needs no coaching or technical competencies for goal obtainment. Serves as a source of expertise in the group for projects
  • Completes projects within schedule & budgetary constraints with allotted resources
  • Ensures change control activities for systems & processes are validated & in compliance with FDA, EU & NN requirements
  • Ensures commissioning activities during projects reduce changes to systems/processes after being placed under formal change control
  • Leads cross functional teams to ensure all support systems (procedures, calibration, maintenance work orders, etc.) are in place for systems associated with projects & serves as a source of expertise
  • Completes accurate & timely assessments associated with change control activities
  • Leads change control efforts for process improvements & identifies opportunities for improvements
  • Other accountabilities, as assigned
  •  

    Physical Requirements

    Ability to work in an open office environment with the possibility of frequent distraction. Ability to travel up to 10% of the time. (% can change on a case-by-case basis based on the role.)

     

    Qualifications

  • Bachelor’s degree in engineering/related field, or equivalent combination of education & experience required
  • Minimum two (2) years of project management, project support or change management experience from GxP production (Pharmaceutical, Nuclear, or Military), with emphasis on IT &/or manufacturing automation required
  • Excellent technical writing & oral communication skills & excellent presentation & facilitation skills preferred
  • Expert knowledge in being a project team leader with excellent negotiation & conflict resolutions skills. Capable of establishing & communicating high standards & expectations for performance & holding team members accountable for results preferred
  • Ability to interact with all levels of the organization preferred
  • Ability to operate with a high level of autonomy & authority preferred
  • Strong analytical/reasoning, organizational & multi-tasking skills preferred
  • High level understanding of infrastructure services & manufacturing automation systems preferred
  • Expert in cGMP documentation practice & understanding of change control processes preferred
  • Expert understanding of validation/system development life cycle approach preferred
  • Basic computer skills including experience in the use of Microsoft Word, PowerPoint, Excel, etc preferred
  • Demonstrated expertise in planning/organizing, managing execution, checking results, & revising the work plan for complex problems being resolved by cross functional teams preferred
  •  

    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.

     

    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.

    Company

    Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 54,400 people in 80 countries and markets its products in around 170 countries. For more information visit novonordisk.com.

    Our US Research & Development hub, located in the Greater Boston area, brings together the best talent to drive life science innovation. Located in Lexington, Watertown and Cambridge, our teams reflect the full scope of R&D, from early research through late-stage clinical development. We are building for the future by creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple modalities and therapeutic areas. We recognize that improving human health starts here and that patients rely on us. By combining the speed and agility of biotech with the quality, resources, and stability of a large pharmaceutical company, our US R&D hub will benefit from the best of both worlds to develop new medicines that meet the needs of patients.

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    Company info
    Website
    Phone
    617-612-6200
    Location
    75 Hayden Avenue
    Lexington
    MA
    02421
    United States

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