Cleaning Validation Senior Specialist

Alexion

Dublin, Ireland
Cleaning validation expertise
Cgmp manufacture of biological bulk drug substance
Upstream and downstream equipment cleaning
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.
  • We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process.

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

  • Cleaning validation expertise
  • cGMP manufacture of biological bulk drug substance
  • Upstream and Downstream equipment cleaning
  • Risk Assessment (QRM tools)
  • Regulatory inspection defense

Nice-to-have

  • Inclusive and equitable environment
  • Adapt to rapidly changing priorities
  • Detail orientated
  • Technical writing competency

Key Requirements

  • Minimum 6+ years' experience
  • Cleaning Validation in biological bulk drug substance manufacturing
  • Technical and operational knowledge of cleaning validation/verification
  • Comprehensive understanding of cGMP requirements
  • Good interpersonal skills
  • Ability to present and defend technical and scientific approaches

Work Rights

Not specified

Tailored Resume

Cover Letter