Validation Specialist

2 days ago


hillsboro, United States BEPC Inc. - Business Excellence Professional Consulting Full time

BEPC Inc. - Business Excellence Professional Consulting is seeking a highly skilled Validation Specialist to join our team in Hillsboro, OR.

Job Summary:

We are looking for a Subject Matter Expert (SME) in the area of validation to support the implementation of standard Manufacturing Execution System (MES) PharmaSuite at HTO. The ideal candidate will have expertise in system setup/configuration, recipe and workflow validation, and interface development.

Key Responsibilities:

  • Develop proficiency in the standard implementation of the PharmaSuite platform.
  • Develop proficiency in interfaces to the PharmaSuite platform, including warehouse management and manufacturing automation systems.
  • Develop understanding of Core practices that need to be adopted at the site.
  • Create project-specific documentation required for implementation.
  • Develop validation test scripts for all system functionality.
  • Finalize and implement master data configuration.
  • Support validation activities, including authoring of test scripts and formal execution.
  • Plan and implement project cutover solutions.

Requirements:

  • Bachelor's degree in Engineering.
  • 5+ years of related experience required.

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