GMP Project manager

4 weeks ago

Fremont, United States Fladger Associates Full time

Responsibilities:

  • Excellent employment opportunity for a Project Manager in the Fremont, CA area.
  • The Project Manager (aka Project Team Lead) ensures the success of the project by tactically monitoring and controlling the Project Triple Constraint, i.e. Scope, Schedule, and Budget, along with administering Risk, Quality and Safety throughout the project lifecycle and the Project Phases, i.e. (a) Investment Intent, (b) Feasibility, (c) Technical Planning, (d) Implementation, and (e) Close…
  • The Project Team Lead will perform the following tasks to achieve project success; (a) monitor project direction and progress, (b) provide oversight, guidance and decisions for project direction and deliverables, (b) provide reporting to Steering Committee and other stakeholders, and (c) facilitate consistent, structured execution of all project phases that is compliant with industry best practices and Company's governances.
  • The Project Lead will provide project oversight and monitor progress to ensure that the Design Intent aligns with the Investment Intent throughout the project lifecycle.
  • Their fiduciary responsibilities to the project have been enumerated below for clarity
  • Organize and lead project team, collaborate with site and global/corporate organization as required
  • Consult and inform Project Sponsor, Steering Committee, and Functional Leads throughout the project lifecycle of project progress, risks, concerns, and achievements.
  • Be accountable for the successful delivery of the project (cost, time, scope, quality and safety)
  • Ensure that a suitable project charter and appropriate user requirements are available.
  • Ensure compliance with local laws and building codes and Company internal regulations and guidelines
  • Ensure / define and implement a project execution plan as well as Risk and Change Management
  • Following defined approval processes described in 100-CCP-00176
  • Align with Global Sourcing the appropriate Project Delivery Method consistent with the guidelines of 100-CCP-00176 RD 04
  • In collaboration with Global Sourcing, manage prequalification and selection of A/E, CM services, contractors and vendors.
  • Manage and monitor contractors in accordance with contractual agreements and project requirements
  • Develop and implement the project organization according to project delivery method for respective project phase
  • Responsible for project implementation including cost, schedule and quality targets
  • Ensure project is executed in accordance with all safety guidelines and requirements
  • Initiate Peer Review and/or Value Engineering workshops with Head of Peer Review
  • Ensures all project tasks, activities are performed timely and with required quality (appropriate documentation for each project phase, construction, installation, commissioning, qualification, validation, start-up activities, etc.)
  • Consider use of benchmarking KPI’s to provide comparable order of magnitude estimations
  • Responsible for project reporting on regular basis (timing aligned with Steering Committee or Project Sponsor)
  • Ensure project close-out is complete and final project report is submitted
  • Ensure handover of all required project documents for operation.
  • Alignment/ Coordination of different stakeholders
  • Ensures project is properly launched, initiated, and closed
  • Ensures best practice sharing at least at the end of a project


Experience:

  • Preference: Bachelor's Degree or over 5 years of experience in a Technical role or, PMP Certification or, Over 7 years of experience as a Project Manager.
  • Must have experience in the Biopharmaceutical Industry and have worked within a GMP Environment.
  • The work-product by the Project Manager will include, but limited to, the following tasks and intellectual property.
  • Develop, submit and obtain signatures on Project Charter
  • Develop, submit and obtain signatures on Scopes of Work
  • Develop, submit and obtain signatures on Project Execution Plan
  • Develop and submit Cost Estimate
  • Develop and submit Project Organizational Chart
  • Develop and submit Key Milestone Schedule
  • Develop, submit and obtain signatures on CapEx Budget Request
  • Develop and execute project buyout plan in accordance with corporate policies.
  • Develop and submit Request for CapEx Project Authorization (RCPA) for qualifying projects.
  • Develop and submit monthly Project Progress Reports to Steering Committee
  • Develop and submit monthly Budget Analysis, Cashflow Projections, and Contingency Utilization to Project Controls and Steering Committee.
  • Accountable to manage and monitor contractors in accordance with contractual agreements and program requirements
  • Develop and implement project organization for respective project phases
  • Initiate with an adequate preparation time a Peer Reviews and/or Value Engineering workshops with Engineering Lead
  • Ensures all project tasks, activities are performed in a timely manner and with required quality
  • Ensure handover of all required project documents to operations
  • Accountable for the financial and project close out of the project in the Post GMP release phase
  • A candidate must demonstrate an ability to communicate and interface with others in a concise structured manner without trepidation.
  • A candidate must demonstrate an ability for critical thinking and critical analysis that is commensurate with their level of experience.
  • A candidate must demonstrate a functional knowledge of project management acumen.
  • Must possess a functional understanding of project management productivity tools; along with standard business productivity applications, capable of learning specialized applications used by the company Fremont.
  • This person must be able to function using Cloud-Based file storage systems, such as OneDrive, Dropbox, and Box.
  • Some management productivity tools have been enumerated below for clarity but should not be interpreted as all inclusive.
  • Microsoft Office Suite, i.e. MSWord, MS Excel, MS Outlook, Microsoft Projects Microsoft Productivity Suite, OneNote, PowerPoint, OneDrive Microsoft SharePoint Adobe DocuSign
  • Required Skills: PHARMACEUTICAL GMP, GOVERNANCE, PROJECT LIFECYCLE, PROJECT MANAGER, PROJECT MANAGEMENT
  • Additional Skills: BUYING/PROCUREMENT, MICROSOFT OFFICE, BI, BUSINESS INTELLIGENCE, MICROSOFT POWERPOINT, MICROSOFT SHAREPOINT,PMI/PMP,PMP,PMP CERTIFICATION,POWERPOINT,PURCHASING,SHAREPOINT,STEERING,STRATEGIC SOURCING,

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