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.
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
cGMP manufacture of biological bulk drug substance
cleaning validation expertise
Upstream and Downstream equipment
cleaning validation documentation
regulatory agency inspections
highest standards for Compliance
Nice-to-have
multiproduct facility experience
build an inclusive and equitable environment
adapt to rapidly changing priorities
Key Requirements
Minimum 6+ years’ experience
Technical and operational knowledge of cleaning validation
Comprehensive understanding of cGMP requirements
Good interpersonal skills
Ability to present and defend technical and scientific approaches
B.Sc. in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering