|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 or directly related equivalent experience. Mandatory
- MA/MS preferred.
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.
- Strong analytical/reasoning, organizational & multi-tasking skills.
- 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.
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:
- Occasionally moves equipment and\\or supplies weighing up to 33 pounds within the facility using various body positions.
- Constantly operates a computer and other office equipment using hands.
- Able to travel internationally, up to 10% 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.
- Able to adjust schedule to work with colleagues in other international time zones.
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.
Requisition ID: 57479BR
Job Category: manufacturing