IT & Automation Project Manager I

About the Department You will be joining Fill & Finish Expansions (FFEx), which is responsible for all major expansion activities within aseptic production, solid dosage forms, finished products, fill & finish warehousing, and QC across all production areas in Product Supply. The area is anchored in Product Supply, Quality & IT, which globally employ approximately 20,000 of Novo Nordisk’s 50,000 employees. FFEx is a newly established and growing area with the responsibility to design, plan, and build all new aseptic filling capacity across Novo Nordisk to serve the needs of millions of patients. We do it by rethinking our production facilities with the use of modern technology, as we are setting the standards for the aseptic production of the future. Facilities designed today which we will still be proud of 20 years from now. FF Expansions has a global approach, where you will be working with multiple sites and cultures across the world. 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 insulin products. Project management includes refining the business case with project owner/sponsor, establishing & communicating quantifiable project benefits, refining & clarifying project scope through early project analysis with subject matter experts & owners, providing clear goals so that the project secures effective use of time & resources & builds employee motivation, developing time/resource estimates to complete projects, developing bid packages, bid evaluation & driving vendor selection and working 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 that the project delivers the desired end-product. Manage, coordinate & direct contract resources, internal resources and ensure that the right amount of resources & competencies is allocated to the project and 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 the 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 & vision. 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 Relationships Reports to Manager, Product & IT Projects. Essential Functions Leads project activities associated with small, medium sized projects. Large projects may be assigned with availability for focus Creates master plans for projects that outline all required activities associated with the projects Develops 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 systems & processes are validated in a compliant manner in accordance 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 Completes accurate & timely assessments associated with change control activities Ensures change control activities for systems are completed in compliance with FDA, EU & NN regulations Leads change control efforts for process improvements & identifies opportunities for improvements Leads cross functional teams during change control efforts & serves as a source of expertise Maintains safe work environment 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 (percentage can change on a case‑by‑case basis based on the role). Qualifications Bachelor’s degree in engineering, computer science or applicable technical degree or directly related equivalent experience preferred Minimum of two (2) years of project management, project support or change management experience from GxP Production (pharmaceutical or nuclear or military), with emphasis on IT and/or manufacturing automation required Excellent technical writing & oral communication skills preferred Excellent presentation & facilitation skills preferred Expert knowledge in being a project team leader with excellent negotiation & conflict resolution 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 Equal Opportunity Statement We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. 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. #J-18808-Ljbffr Initial Therapeutics, Inc.