IT & Automation Project Manager

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.

• 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

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 the following activities: 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 that 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 that the project delivers the desired end-product.

Manage, coordinate & direct contract resources, coordinate & direct internal resources; ensure that the right amount of resources & competences is allocated to the project & negotiate project resources with Line of Business (LoB) management. Report project performance to 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 & visions.

Reports to Manager, Product & IT Projects.

• Projects:
  • 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
  • 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 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
• Change Control:
  • Completes accurate & timely assessments associated with change control activities
  • Ensures change control activities for systems are completed in a manner 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

Ability to work in an open office…