Posted to MedZilla on 7/21/2018


Novo Nordisk

US-NC, Project Manager 2 - IT & Automation Job 486225900A0-MZ


 
 

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.

Accountabilities:
Projects:
  • 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.

Investigations:
  • 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.

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.

Education:
  • BA/BS in Engineering, Computer Science, or applicable technical degree or directly related equivalent experience. Mandatory
  • MA/MS preferred.
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.

Technical/Process/Functional Knowledge:
  • 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.

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:
  • 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.

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.


Requisition ID: 57479BR
State/Provinces: Clayton
Job Category: manufacturing


Please visit our website at www.novonordisk.com

 
 


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