At Astellas, we foster an inspiring work environment where you can make a meaningful difference in the lives of others. Our company combines expertise, science, and technology to deliver innovative solutions.
We have a culture that embodies our commitment to doing good for others and contributing to a sustainable society. This is reflected in our global vision for Patient Centricity, which focuses on creating innovative health solutions through a deep understanding of the patient experience.
Astellas is guided by the Astellas Way, consisting of five core values: patient focus, ownership, results, openness, and integrity. We strive to maintain an inclusive and respectful work environment that encourages collaboration and ownership.
About This Job
The Graduate Operations Engineer will be responsible for supporting equipment troubleshooting in biologics manufacturing, ensuring compliance with regulatory standards (e.g., FDA, EMA) and Good Manufacturing Practices (GMP). The role involves collaborating with Validation Engineers to develop validation protocols, performing data analysis, and identifying areas for process improvement.
This position offers a unique opportunity to work in an international setting and contribute to the development of innovative therapies for patients.
Key Activities
* Department Operation: Contribute to the development of operational/maintenance procedures to achieve best practice and regulatory compliance.
* Monitor equipment performance and initiate actions to avoid problems and maximize reliability.
* Support Change Control and Commissioning/Qualification activities.
* Continuous Improvement: Support Kaizen, Lean/Six Sigma, and Problem-solving methodologies.
* Reporting: Regularly report to the Operations Lead and provide feedback on equipment performance.
Requirements
* Bachelor's degree in engineering or a relevant science discipline.
* Familiarity with ISPE baseline Guide for Commissioning and Qualification.
* Strong understanding of pharmaceutical quality management systems and regional Good Manufacturing Practices.
* Experience with QMS tools such as TrackWise, Valgenesis, and Vault.
This is a 2-year fixed-term contract based in our Irish office (Kerry plant), offering a challenging and diversified job in an international setting. We are committed to continuous learning and improvement within the pharmaceutical manufacturing environment.