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Project Engineer (for Manufacturing / GMP Projects)

The Project Engineer is the designated Amgen person responsible for coordinating the project's engineering issues. PE roles and responsibilities in the project support process are as follows:

Phase I

Phase II

  • Participate in the design of the project documentation flows

  • Consult with the PC about documentation and project support procedures and requirements

  • Define and deliver manufacturing, validation and maintenance requirements for the project turnover documentation

  • Comply with project support documentation procedures and requirements

  • Monitor development of the project turnover documentation

  • Deliver project documentation to the PC for filing, provide the document

file number when authoring the document

  • Respond to any Project Correspondence in a timely manner

Phase III

All Phases

  • Participate in the review of the TOP

  • Lead the review of the TOP documentation being transitioned to Manufacturing, Validation and Maintenance/Operations (the Installation Verification package)

  • Support Project Coordinator in the interpretation of documentation

categories so they can be filed appropriately

Roles and Responsibilities

2-5

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