This role is a 12 month fixed term contract
Introduction to role
The Technical Operations Team provides manufacturing support to complex life changing biological products. Support new product introductions, process monitoring, investigations, changes, improvement projects, technical training, operational excellence and documentation. This role also requires Operations input into Manufacturing Execution System (MES) team to effect design, approval, testing and release of electronic Batch Records (eBRs).
The team provides a key interface between the shift operations teams and day-based cross functional support. Manufacturing Specialists provide key timely front line Operations technical support to the BDS processes during all phases of facility and product start up and into ongoing commercial supply.
The Manufacturing Specialist are also responsible for the successful execution of projects and improvements identified as part of the Dublin facility priority list. These are in several categories, including: new process / equipment introduction/remediation/optimisation (CAPEX & OPEX), process innovation, automation, product transfers, process feature optimisation & enhancements, new material introduction, equipment qualification, continuous improvement / cost reduction in facility and process operation.
Accountabilities
* Supporting eBR project
* Liaise closely with internal Manufacturing Operations stakeholders to successfully support eBR introduction.
* Develop and implement standard operating procedures and work instructions to complement eBRs.
* 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 support and championing electronic Batch Records across manufacturing shift operations.
* Ownership of change control.
Essential Skills/Experience
* Experience of working in Drug Substance Manufacturing Operations.
* Knowledge of processes, procedures and equipment within the Drug Substance environment.
* 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 systems.
Desirable Skills/Experience
* Experience of change management in a complex environment.
* Understanding of manufacturing computer systems and Data Integrity requirements.
* Experience of developing or supporting the lifecycle of Paper Batch Records.
* Knowledge of SAP and MCS.
At Alexion, AstraZeneca Rare Disease, we embrace an opportunity where work isn’t ordinary. Our closeness to patients brings us closer to our work and each other. With a rapidly expanding portfolio, we foster an entrepreneurial spirit and autonomy. Our culture values diversity and inclusion, encouraging new ideas that profoundly impact patients' lives. We celebrate and reward each other, ensuring kindness remains as important as our ambition to succeed. Join us in making a difference where it truly counts.
Ready to make an impact? Apply now!
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