Cleaning Validation Senior Specialist

Alexion

Dublin, Ireland
Cgmp manufacture of biological bulk drug substance
Cleaning validation expertise
Upstream and downstream equipment
The Cleaning Validation Senior Specialist has primary responsibility in supporting the cleaning validation activities for the cGMP manufacture of biological bulk drug substance (BDS) at Alexion’s facility in Blanchardstown, Dublin

Job Summary

  • The Cleaning Validation Senior Specialist has primary responsibility in supporting the cleaning validation activities for the cGMP manufacture of biological bulk drug substance (BDS) at Alexion’s facility in Blanchardstown, Dublin.
  • The person should have experience in leading cleaning programs for Upstream and Downstream equipment, Cleaning Validation (CV), Cleaning Monitoring, Risk Assessment (using QRM tools), and building strategies / SME capability.
  • Our mission is to build an inclusive and equitable environment.

Matching Summary

The Cleaning Validation Senior Specialist has primary responsibility in supporting the cleaning validation activities for the cGMP manufacture of biological bulk drug substance (BDS) at Alexion’s facility in Blanchardstown, Dublin.

Skills & Requirements

Must-have

  • cGMP manufacture of biological bulk drug substance
  • cleaning validation expertise
  • Upstream and Downstream equipment
  • Risk Assessment using QRM tools
  • leading cleaning programs
  • regulatory inspection defense

Nice-to-have

  • build an inclusive and equitable environment
  • adapt to rapidly changing priorities
  • detail orientated
  • technical writing competency

Key Requirements

  • Minimum 6+ years’ experience
  • B.Sc. in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering

Work Rights

Not specified

Tailored Resume

Cover Letter