Description
Graduate Operations Engineer
About Astellas
At Astellas we are making treatments that matter to people.
We are tackling the toughest health challenges putting the patient at the heart of every move we make.
Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn't a buzzword - it's a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.
We have developed ground-breaking, innovative medicines in immunology, oncology and urology. Our medicines are extending and saving the lives of cancer patients, making transplantation possible and improving the quality of life for those living with conditions where needs are often overlooked.
We take a patient-focused approach, that allows us to convert brilliant early science into treatments and solutions that directly improve and save patients' lives.
From lab to clinic to patient, we focus on the most promising science, empower the best talent to pursue it, and develop life-changing solutions alongside the best partners.
The Opportunity
They support troubleshooting of equipment used in biologics manufacturing while ensuring full compliance with regulatory standards such as those set by the FDA and EMA, as well as adherence to Good Manufacturing Practices (GMP). In collaboration with Validation Engineers, they contribute to the development and execution of validation protocols. They also perform data analysis to verify manufacturing and test readiness and proactively identify areas for process improvement, implementing effective solutions to enhance operational efficiency and product quality.
Responsibilities
* Develop and maintain operational and maintenance procedures to ensure best practices and regulatory compliance.
* Provide technical support, troubleshooting, and investigation resolution within the area.
* Generate and analyze data and reports to support business operations and decision-making.
* Monitor equipment performance, address non-conformances, and implement actions to improve reliability and efficiency.
* Contribute engineering input to projects, including Change Control, Commissioning/Qualification, and Continuous Improvement initiatives (Kaizen, Lean, Six Sigma).
* Report regularly to the Operations Lead, communicating equipment performance, potential issues, and updates from relevant meetings.
Education
* Minimum bachelor's degree in engineering or relevant science discipline.
Additional Information
* This is a graduate scheme opportunity
* Position is based in Tralee – Ireland
* This position requires you to be 100% on site / in the office
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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