Cleaning Validation Technical Specialist

As a Cleaning Validation Technical Specialist, 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. Are you ready to make a significant impact in the world of biopharmaceutical manufacturing?

Accountabilities

- Prepare and review relevant cleaning validation documentation including but not limited to protocols, reports, plans, risk assessments, technical/impact assessments.

- Provide input on cleaning processes and troubleshoot/support cleaning activities related to both commercial operations and new product introduction.

- Provide support for the technical services team during regulatory agency inspections.

- Identify operational process improvements using Lean Tools.

- Assist with the investigation of and operations deviations through the eQMS system, engaging with all relevant personnel and functions as appropriate.

- Participate in technical projects, inclusive of process optimisation projects.

- Responsibility for Change Management and Deviation Management.

- Manage competing priorities to ensure timely delivery of tasks.

- Collaborate closely with various departments and lead cleaning programs for Upstream and Downstream equipment.

- Possess technical and operational knowledge of cleaning validation/verification of upstream and downstream equipment, quality systems, and regulatory requirements across multiple health authorities.

- Have a comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing.

Essential Skills/Experience

- NFQ Level 5, or equivalent, with prior experience or Entry Level Bachelor’s Degree preferred in a scientific discipline such as Biochemistry, Biology, Chemistry or B.Eng. Process or Chemical Engineering or equivalent.

- Minimum of three years experience in cleaning validation

- Experience in preparation of routine documentation to GMP standard

- Experience working with digital tools and applications (MS Office, Adobe etc)

- Ability to read, comprehend and prepare applicable documentation required

Desirable Skills/Experience

3-5 year’s experience in cleaning validation in a biological manufacturing environment.

- Knowledge of downstream purification processes such as ultrafiltration is desirable.

- Experience in lean processing is an advantage.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, we are at the forefront of biomedical science, pushing boundaries to translate complex biology into transformative medicines. Our commitment to rare disease biopharma means we are uniquely positioned with resources and global reach to shape the future of healthcare. Our culture is rooted in integrity, inclusiveness, and dedication to making a difference for people living with rare diseases.

Ready to make an impact? Apply now and 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.