Cleaning Validation Senior Specialist

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.

Requirements

• Minimum 6+ years' experience in Cleaning Validation in a biological bulk drug substance manufacturing organization
• Technical and operational knowledge of cleaning validation/verification of upstream and downstream equipment, quality systems and regulatory requirements across multiple health authorities
• Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing
• Good interpersonal skills coupled with demonstrated ability to effectively work in a matrix organization and in local group settings
• Ability to present and defend technical and scientific approaches in both written and verbal form
• Ability to drive for results independently and adapt to rapidly changing priorities
• Detail orientated
• Technical writing competency

Benefits

• Reasonable adjustments/accommodations to help all candidates to perform at their best