This role leads the end-to-end Validation function at Amgen's Dun Laoghaire site, ensuring compliance with global standards and inspection readiness
Job Summary
This role leads the end-to-end Validation function at Amgen's Dun Laoghaire site, ensuring compliance with global standards and inspection readiness.
The Director will oversee critical activities including aseptic process simulations, cleaning validation, and major capital project commissioning for new syringe filling lines.
Candidates must possess a Doctorate or Master's degree with extensive managerial experience in sterile manufacturing validation environments.
Matching Summary
This role leads the end-to-end Validation function at Amgen's Dun Laoghaire site, ensuring compliance with global standards and inspection readiness.
Skills & Requirements
Must-have
Sterile fill-finish manufacturing experience
Aseptic process simulation (media fills)
Commissioning and qualification (CQV) expertise
cGMP regulatory compliance knowledge
Validation master plan development
Nice-to-have
Lean principles and continuous improvement
Unionized environment labor relations
Digitalisation initiatives in validation
Global matrix organization collaboration
Key Requirements
Doctorate degree plus 4 years relevant experience
Master's degree plus 8 years relevant experience
Bachelor's degree plus 10 years relevant experience
4 years of direct managerial experience
Deep knowledge of FDA, EMA, and EU GMP Annex 1 regulations