Position Purpose: 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 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, & visions.
Leads project activities associated with large, medium sized projects.
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.
Leads the closure of investigations per approved timeframes.
Requires no guidance & direction to complete these goals & needs no coaching on technical competencies for goal attainment. Serves as a source of expertise in the group for investigations.
Leads cross functional teams to determine the root cause & corrective actions for problems associated with investigations.
Regulatory Audits: Project documentation is successfully reviewed during audits without compliance issues.
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.
BA/BS in Engineering, Computer Science, or applicable technical degree. Mandatory
Experience: Mandatory Min. 5 years of project management experience from GxP Production (Pharmaceutical or Nuclear or Military), with emphasis on within IT &/or Manufacturing Automation.
Excellent technical writing & oral communication skills.
Excellent presentation & facilitation skills.
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.
Ability to interact with all levels of the organization.
Able to operate with a high level of autonomy & authority.
High level understanding of infrastructure services & manufacturing automation systems.
Expert in cGMP documentation practice & understanding of change control processes.
Expert understanding of validation/system development life cycle approach.
Basic computer skills including experience in the use of Microsoft word, power point, excel, etc.
Organization/Planning: Demonstrated expertise in planning/organizing, managing execution, checking results, & revising the work plan for complex problems being resolved by cross functional teams.
Physical & Other Requirements:
Ability to lift up to 40 lbs. with assistance.
Ability to work in confined spaces & near operating equipment.
Ability to work in loud noisy environments with hearing protection.
Ability to work hours necessary to support a 24/7 production operations & /or maintenance activities.
EEO Statement: Novo Nordisk is an Equal Opportunity Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity.
Novo Nordisk is not currently hiring individuals for this position who now or in the future would require sponsorship for employment visa status.
Internal Number: 53134BR
About Novo Nordisk
At Novo Nordisk, we are driving change to defeat diabetes and other serious chronic conditions.Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: rare bleeding disorders, growth hormone related disorders and obesity.Headquartered in Denmark, Novo Nordisk employs approximately 42,000 people in 77 countries and markets its products in more than 165 countries.