Description
TOP SKILLS PER MGR:
1. IT Project Knowledge
2. Detailed oriented
3. Flexible to change/Great personality
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 API.
Assist in managing the IT Automation roadmap (project portfolio).
ESSENTIAL FUNCTIONS:
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 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 the project delivers the desired end-product.
Manage, coordinate & direct contract/internal resources.
Ensure 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 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 projects of all sizes.
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 change control activities for systems & processes are validated & in compliance 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 & serves as a source of expertise.
Completes accurate & timely assessments associated with change control activities.
Leads change control efforts for process improvements & identifies opportunities for improvements.
Other accountabilities, as assigned.
QUALIFICATIONS:
Bachelor's Degree in engineering/related field, or equivalent combination of education & experience required.
Minimum two (2) years of project management, project support or change management experience from GxP production (Pharmaceutical, Nuclear, or Military), with emphasis on IT &/or manufacturing automation required.
Excellent technical writing & oral communication skills & excellent presentation & facilitation skills preferred.
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 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.
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