Director - Site Validation

Amgen UK

Dun Laoghaire, Dublin, Ireland
Not specified; not specified; generous total rewar...
Hybrid
Sterile fill-finish manufacturing validation
Aseptic process simulation media fills
Commissioning and qualification cqv
The role involves leading the end-to-end validation function for a critical sterile fill-finish manufacturing site supporting commercial operations and expansion

Job Summary

  • The role involves leading the end-to-end validation function for a critical sterile fill-finish manufacturing site supporting commercial operations and expansion.
  • Candidates must ensure strict compliance with cGMP regulations including FDA, EMA, and EU GMP Annex 1 while maintaining inspection readiness at all times.
  • Amgen offers a diverse and inclusive community where employees can access vast opportunities to learn and move up across their global organisation.

Matching Summary

The role involves leading the end-to-end validation function for a critical sterile fill-finish manufacturing site supporting commercial operations and expansion.

Salary

Not specified; Not specified; Generous Total Rewards Plan including health finance and wealth benefits

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

Nice-to-have

  • Lean principles continuous improvement
  • Digitalisation of validation processes
  • Unionised environment labour relations
  • Global matrix organisation leadership
  • Technology transfer expertise

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 directly managing people or leading teams
  • Extensive experience in sterile aseptic manufacturing validation environments

Work Rights

Not specified

Tailored Resume

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