Cleaning Validation Senior Specialist

Vacancyz

Dublin, , IE
**
Cleaning validation for upstream and downstream equipment
Cgmp compliance in biopharmaceutical manufacturing
Risk assessment using qrm tools
** The Cleaning Validation Senior Specialist position at Vacancyz in Dublin focuses on overseeing cleaning validation activities for the cGMP manufacture of biological bulk drug substances. The role requires extensive experience in cleaning validation, technical documentation, and collaboration with various departments to ensure compliance and operational efficiency. **

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 where people feel they belong, starting with our recruitment process.

Matching Summary

Match Score: 75

** The Cleaning Validation Senior Specialist position at Vacancyz in Dublin focuses on overseeing cleaning validation activities for the cGMP manufacture of biological bulk drug substances. The role requires extensive experience in cleaning validation, technical documentation, and collaboration with various departments to ensure compliance and operational efficiency. **

Skills & Requirements

Must-have

  • Cleaning validation for upstream and downstream equipment
  • cGMP compliance in biopharmaceutical manufacturing
  • Risk assessment using QRM tools
  • Technical writing for cleaning validation
  • Regulatory inspection support
  • Cleaning cycle optimisation and process improvements

Nice-to-have

  • Experience in multiproduct facility cleaning approaches
  • Ability to work effectively in matrix organizations
  • Presentation and defense of scientific approaches
  • Detail oriented
  • Collaboration with cross-functional teams

Key Requirements

  • Minimum 6+ years experience in cleaning validation
  • Technical and operational knowledge of cleaning validation/verification
  • Comprehensive understanding of cGMP requirements
  • B.Sc. in Biochemistry, Biology, Chemistry or equivalent or B.Eng. Process or Chemical Engineering

Work Rights

Not specified

Tailored Resume

Cover Letter