Cgmp manufacture of biological bulk drug substance
Cleaning validation expertise
Upstream and downstream manufacturing
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 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.
We offer reasonable adjustments/accommodations to help all candidates to 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 (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 manufacturing
risk assessment using QRM tools
leading cleaning programs
presenting and defending cleaning validation strategies
Nice-to-have
building strategies and SME capability
inclusive and equitable environment
adapt to rapidly changing priorities
detail oriented
technical writing competency
Key Requirements
Minimum 6+ years' experience
Technical and operational knowledge
Comprehensive understanding of cGMP requirements
Good interpersonal skills
Ability to present and defend technical approaches
Experience in cleaning validation for multiproduct facility is advantageous