Director - Site Validation

Amgen

Dun Laoghaire, Ireland
On-site
Sterile manufacturing validation expertise
Cgmp compliance and regulatory expectations
Leadership of multidisciplinary validation teams
Amgen is seeking a Director of Site Validation for its Dun Laoghaire, Ireland facility to lead validation functions crucial for commercial operations and site expansion. The ideal candidate will have extensive experience in sterile manufacturing validation, strategic leadership capabilities, and a strong understanding of regulatory compliance

Job Summary

  • Lead the end-to-end Validation function, ensuring compliance, inspection readiness, and operational excellence for commercial operations and site expansion.
  • Oversee commissioning and qualification (CQV) activities for major capital projects, including new syringe filling and inspection lines.
  • Develop and manage departmental budgets, resource planning, and long-term capability strategies while building and sustaining a high-performing organization.

Matching Summary

Match Score: 85

Amgen is seeking a Director of Site Validation for its Dun Laoghaire, Ireland facility to lead validation functions crucial for commercial operations and site expansion. The ideal candidate will have extensive experience in sterile manufacturing validation, strategic leadership capabilities, and a strong understanding of regulatory compliance.

Skills & Requirements

Must-have

  • Sterile manufacturing validation expertise
  • cGMP compliance and regulatory expectations
  • Leadership of multidisciplinary validation teams
  • Commissioning and qualification for capital projects
  • Aseptic process simulation and media fills

Nice-to-have

  • Continuous improvement and operational excellence
  • Risk-based validation approaches
  • Stakeholder management in a global organization
  • Driving digitalization initiatives
  • Experience in a unionized environment

Key Requirements

  • Doctorate degree and 4 years of experience OR Master’s degree and 8 years of experience OR Bachelor’s degree and 10 years of experience
  • 4 years of managerial or leadership experience
  • Experience in sterile/aseptic manufacturing validation
  • Expertise in media fills, cleaning validation, equipment qualification, and CQV for capital projects
  • Knowledge of cGMP regulations (FDA, EMA, HPRA)

Work Rights

Not specified

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