At Astellas we can offer an inspiring place to work and a chance to make your mark in doing good for others.
Our expertise, science and technology make us a pharma company. Our open and progressive culture is what makes us Astellas. It’s a culture of doing good for others and contributing to a sustainable society.
Delivering meaningful differences for patients is our driving force. We all have a significant opportunity to make that difference, working locally in the areas we know best, whilst drawing inspiration from the different insights and expertise we have access to globally and from our innovative, external partners.
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.
Our ethos is underpinned by the Astellas Way, comprising five core values: patient focus; ownership; results; openness and integrity.
We are proud to offer an inclusive and respectful working environment that fosters collaboration and ownership.
Our aspiration is to bring the best brains together, to provide them with world-leading tools and resources and a unique structure that fosters real agility and entrepreneurial spirit.
About This Job
As a Graduate Operations Engineer, you will be responsible for supporting the troubleshooting of equipment used in biologics manufacturing, ensuring compliance with regulatory standards (e.g., FDA, EMA) and Good Manufacturing Practices (GMP), collaborating with Validation Engineers to develop and execute validation protocols, performing data analysis to ensure manufacturing and test readiness, and identifying areas for process improvement and implementing solutions.
You will be part of an inclusive team that works to develop innovative therapies for patients.
Key Activities for this role
1. Department Operation:
2. Contribute to and help develop operational/maintenance procedures to achieve and maintain best practice and regulatory compliance.
3. Provide support to monitor and analyse equipment performance and initiate actions to avoid possible problems and maximise equipment reliability, robustness and availability.
4. Projects Support:
5. Support of Change Control and Commissioning/Qualification activities.
6. Support Continuous Improvement through Kaizen, Lean/Six Sigma and Problem-solving methodologies.
7. Reporting:
8. Report regularly to the Operations Lead.
9. Feedback performance of the equipment, potential problems quickly and accurately, e.g., resources, technical issues, etc.
10. Strong understanding of aseptic manufacturing techniques.
11. Familiarity with the ISPE baseline Guide for Commissioning and Qualification.
12. Solid understanding of pharmaceutical quality management systems.
13. Experience with various QMS tools, such as TrackWise, Valgenesis, and Vault.
14. Thorough knowledge and understanding of regional Good Manufacturing Practices for pharmaceutical products.
15. Commitment to continuous learning and improvement within the pharmaceutical manufacturing environment.
Education/Qualifications
1. Bachelor’s degree in engineering or relevant science discipline.
Additional Information
1. Type of role: 2 years fixed term contract.
2. Location: Irish office (Kerry plant).
3. This position is field-based.
What We Offer
1. A challenging and diversified job in an international setting.
2. Opportunity and support for continuous development.
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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