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Sr Validation Engineer

Amgen Inc.

3.6

(9)

Dublin, Ireland

Why you should apply for a job to Amgen Inc.:

  • 67% say women are treated fairly and equally to men
  • 78% would recommend this company to other women
    • Ratings are based on anonymous reviews by Fairygodboss members.
  • Flexible work models that empower staff members to work where and when they are most productive
  • Award-winning PTO plan and bi-annual company-wide shutdowns
  • With 11 Employee Resource Groups, 60 chapters & 11000 members everyone has opportunity to connect, network & foster a culture of belonging

    • #R-193599

    Position summary

    ion maintenance activities.

    • Translate Amgen requirements into the language of the CMO

    • Identify and assess validation/quality risks to enable risk-based decisions

    • Validation document author/approver

    • Aseptic processing system oversight (media fill, autoclave validation, EM)

    • Prepare materials/documents (playbooks) for topics to be presented during audits/inspections

    • Perform validation change control assessments

    • Review/approve validation deviations

    • Review/approve Master Batch Records

    • Perform Person in Plant activities as required

    • Escalate issues to Validation/Quality management, as needed

    • Write/review responses to regulatory questions (RTQs)

    • Drive Operational Excellence and Champion Change

    Authority

    • Determine outcome of validation activities

    • Decision to approve or reject validation documentation

    • Provide input on Validation position on related topics and strategy for the site

    • Decision to approve Master batch Records

    .

    Why you should apply for a job to Amgen Inc.:

  • 67% say women are treated fairly and equally to men
  • 78% would recommend this company to other women
    • Ratings are based on anonymous reviews by Fairygodboss members.
  • Flexible work models that empower staff members to work where and when they are most productive
  • Award-winning PTO plan and bi-annual company-wide shutdowns
  • With 11 Employee Resource Groups, 60 chapters & 11000 members everyone has opportunity to connect, network & foster a culture of belonging