Cleaning Validation Senior Specialist

Zse68

Dublin, , Ireland
Cleaning validation for upstream equipment
Cleaning validation for downstream equipment
Cgmp compliance in biopharmaceuticals
The Cleaning Validation Senior Specialist has primary responsibility in supporting the cleaning validation activities for the cGMP manufacture of biological bulk drug substance 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 at Alexion’s facility in Blanchardstown, Dublin.
  • The person will be required to work in close collaboration with Operations, Engineering, Supply Chain, Quality, Quality Control, Regulatory and other involved departments to provide successful cleaning support.
  • Our mission is to build an inclusive and equitable environment and we offer reasonable adjustments/accommodations to help all candidates perform at their best.

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 at Alexion’s facility in Blanchardstown, Dublin.

Skills & Requirements

Must-have

  • Cleaning validation for upstream equipment
  • Cleaning validation for downstream equipment
  • cGMP compliance in biopharmaceuticals
  • Cleaning monitoring and risk assessment
  • Technical writing for cleaning documentation
  • Regulatory inspection defense expertise

Nice-to-have

  • Experience in multiproduct facility cleaning
  • Ability to work in matrix organizations
  • Presentation and communication skills
  • Troubleshooting cleaning deviations
  • Process improvement implementation
  • Adaptability to changing priorities

Key Requirements

  • Minimum 6+ years cleaning validation experience
  • Experience in biological bulk drug substance manufacturing
  • Technical knowledge of upstream and downstream equipment cleaning
  • Comprehensive understanding of cGMP requirements
  • B.Sc. in Biochemistry, Biology, Chemistry or equivalent preferred
  • B.Eng. Process or Chemical Engineering preferred

Work Rights

Not specified

Tailored Resume

Cover Letter