Cleaning Validation Senior Technical Specialist

Introduction to Role:

Join us at Alexion AstraZeneca Rare Disease as a Cleaning Validation Senior Specialist, where you will play a pivotal role in supporting the cleaning validation activities for the cGMP manufacture of biological bulk drug substance (BDS) at our facility in Blanchardstown, Dublin. This role requires close collaboration with various departments and offers the opportunity to lead cleaning programs for Upstream and Downstream equipment. If you have experience in presenting and defending cleaning validation strategies during regulatory inspections, this could be the perfect role for you!

This is what you will do:

As a Cleaning Validation Senior Technical Specialist, you will provide cleaning expertise in Upstream and Downstream equipment, author and review cleaning related documentation, identify requirements for laboratory studies to support cleaning decisions, and implement cleaning related process improvements. You will also serve as a subject-matter expert (SME) on cleaning of Upstream and Downstream equipment and provide on the floor support for troubleshooting cleaning related issues.

You will need to have:

• Minimum 6+ years’ Cleaning Validation experience in a biological bulk drug substance manufacturing organisation
• 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 proven ability to work effectively in a matrix organisation 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 evolving priorities
• Experience in cleaning validation and cleaning approaches to a multiproduct facility is advantageous
• Detail orientated
• Technical writing proficiency

We would prefer for you to have:

• B.Sc. in Biochemistry, Biology, Chemistry or B.Eng. Process or Chemical Engineering or equivalent

At Alexion AstraZeneca Rare Disease, you'll be part of a team of specialists that is valued and essential to our growth. We encourage entrepreneurial and innovative thinking in a rigorous, regulated environment.

Ready to make an impact? Apply now to join us on this exciting journey!

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.