The role provides strategic and technical leadership across the end-to-end validation function to ensure compliance and operational excellence at the Dun Laoghaire site
Job Summary
The role provides strategic and technical leadership across the end-to-end validation function to ensure compliance and operational excellence at the Dun Laoghaire site.
The Director will lead a large multidisciplinary team responsible for aseptic process simulations, cleaning validation, and major capital project commissioning activities.
Amgen offers a diverse community of belonging with generous total rewards plans including health benefits and flexible work models where possible.
Matching Summary
The role provides strategic and technical leadership across the end-to-end validation function to ensure compliance and operational excellence at the Dun Laoghaire site.
Skills & Requirements
Must-have
Sterile fill-finish manufacturing validation
Aseptic process simulation media fills
Commissioning and qualification CQV
cGMP regulatory compliance FDA EMA
Validation master plan development
Risk-based validation approaches
Capital project delivery oversight
Nice-to-have
Continuous improvement LEAN principles
Digitalisation initiatives in validation
Unionised environment labour relations
Global matrix organisation navigation
Technology transfer leadership
Contamination control strategy input
Key Requirements
Doctorate degree plus 4 years experience OR Master's plus 8 years OR Bachelor's plus 10 years
Minimum 4 years of managerial experience leading teams or projects
Extensive experience in sterile/aseptic manufacturing validation environments
Deep knowledge of cGMP regulations (FDA, EMA, HPRA)
Proven ability to lead during regulatory inspections and audits