Operations MES System Specialist

Introduction to role:

Are you ready to make a difference in the world of biopharmaceutical manufacturing? Join us at the Alexion facility in Blanchardstown, Dublin, where you'll play a pivotal role in shaping the future of Manufacturing Execution Systems (MES). As an Operations MES System Specialist, you'll be at the forefront of designing, testing, and implementing electronic Batch Records (eBRs), ensuring seamless integration into our manufacturing processes. Dive into a dynamic environment where your expertise will drive process optimization and compliance.

Accountabilities:

• Support eBR establishment projects.

• Collaborate closely with internal Manufacturing Operations stakeholders to ensure successful eBR introduction.

• Develop and implement standard operating procedures and work instructions to enhance eBR use.

• Contribute to the development of eBR design documentation and master data for process optimization. Review and approve eBR documents and data.

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

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

• Provide ongoing support for MES issues during routine production to maintain compliance.

• Take ownership of change control.

Essential Skills/Experience:

• 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.

Desirable Skills/Experience:

• 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.

At AstraZeneca, we are driven by a patient-focused ethos that inspires us to innovate and create meaningful value. Our culture is rooted in integrity, inclusiveness, and dedication to supporting the communities we serve. Here, diversity and different thinking are valued, empowering us to explore new ideas that profoundly impact patients' lives. With a rapidly expanding portfolio, we offer an entrepreneurial spirit combined with the strength and resources of a global biopharma. Join us in making a difference where it truly counts.

Ready to embark on this exciting journey? Apply now and be part of a team that is transforming lives!

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.