This is what you will do:

This position is based at the Alexion facility in Blanchardstown, Dublin. This role provides Operations input into Manufacturing Execution System (MES) team to design, approval, testing, release and sustain the use of electronic Batch Records (eBRs).

You will be responsible for:

· Supporting eBR establishment projects.

· Liaise closely with internal Manufacturing Operations stakeholders to successfully support eBR introduction.

· Develop and implement standard operating procedures and work instructions to complement eBR use.

· Contribute to development of eBR design documentation and master data to drive process optimisation. Review and approval of eBR documents and data.

· Support development, approval and execution of Operational Release Testing of eBRs.

· Assist in classroom and production floor training and championing electronic Batch Records across manufacturing shift operations.

· Ongoing support for MES issues during routine production and to maintain compliance.

· Ownership of change control.

You will need to have:

· 2 years or more experience of working in Drug Substance Manufacturing Operations.

· Knowledge of Pharmceutical manufacturing processes, procedures and equipment within a Drug Substance environment.

· Lean manufacturing and optimisation mindset.

· Willingness to widen knowledge of manufacturing processes.

· Experience of process mapping in a manufacturing environment.

· Comprehensive understanding of cGMP requirements for commercial biopharmaceutical manufacturing

· Good interpersonal skills are required, as is the ability to communicate well, both verbally and within written documents.

· Experience of use of MES system.

We would prefer for you to have:

· Experience of change management in a complex environment.

· Understanding manufacturing computer systems and eData Integrity requirements.

· Experience of developing or supporting the lifecycle of Paper Batch Records.

· Knowledge of SAP and MCS.

Date Posted

03-Feb-2026

Closing Date

02-Mar-2026

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.

Operations MES System Specialist

Job Description