Operations MES System Specialist

Operations Role At 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.

• Liaising closely with internal Manufacturing Operations stakeholders to successfully support eBR introduction.

• Developing and implementing standard operating procedures and work instructions to complement eBR use.

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

• Supporting development, approval and execution of Operational Release Testing of eBRs.

• Assisting 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 pharmaceutical 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.