Senior Manufacturing Engineer
Astellas is a pharmaceutical company that offers an inspiring place to work and the opportunity to make a positive impact on people's lives.
Our expertise, science, and technology drive our business forward. Our open and progressive culture is at the heart of what makes us Astellas. We are committed to creating a sustainable society and delivering meaningful differences for patients.
As a Senior Manufacturing Engineer, you will have the opportunity to work locally while drawing inspiration from global insights and expertise. You will be part of a team that shares a deep understanding of the patient experience and is dedicated to creating innovative health solutions.
We believe that all staff have a role to play in creating a patient-centric culture. Our ethos is underpinned by the Astellas Way, which comprises five core values: patient focus, ownership, results, openness, and integrity.
**Responsibilities:**
• Install, maintain, and troubleshoot equipment used in biologics manufacturing while ensuring compliance with regulatory standards (e.g., FDA, EMA) and GMP.
• Implement corrective actions to address deviations and improve product quality, collaborating with Validation Engineers to develop and execute validation protocols.
• Perform data analysis to ensure manufacturing and test readiness, contribute to lean manufacturing initiatives, and identify areas for process improvement.
• Work closely with global product design, Quality, Operations, and Engineering teams to align manufacturing processes with product development goals.
• Become an expert in Aseptic Filling and Lyophilisation, leading cross-functional meetings to optimize machine operations.
Requirements:
• Minimum bachelor's degree in engineering or related field or equivalent.
**Working Conditions:**
This is a permanent full-time position based in Tralee, Ireland. The successful candidate will be required to be 100% on-site in the office.