Job Description
About Astellas
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.
The opportunity
- The Manufacturing Engineer is responsible for the installation, maintenance, and troubleshooting of equipment used in biologics manufacturing while ensuring compliance with regulatory standards (e.g., FDA, EMA) and Good Manufacturing Practices (GMP).
- Provide daily technical support, troubleshooting, and collaborate with Operations and Engineering Teams to optimize equipment design and performance.
- Develop and implement guides, procedures, and training to improve equipment operation and troubleshooting.
- Lead technical problem-solving efforts and provide expertise on process improvements, focusing on quality and efficiency.
- Collaborate with Validation Engineers to create and execute validation protocols, ensuring manufacturing and test readiness.
- Contribute to lean manufacturing initiatives, process improvements, and cross-functional alignment between product design, Quality, Operations, and Engineering teams.
- Become an expert in Aseptic Filling and Lyophilization processes, leading meetings to optimize machine operations and support product development goals.
Essential Knowledge & Experience
- Extensive experience in Biologics/Pharmaceutical manufacturing or a relevant GMP environment, with a focus on aseptic filling and lyophilization.
- Strong interpersonal and collaborative skills, thriving in a fast-paced team environment and contributing to a positive, supportive workplace.
- Flexibility to support GMP Operations with a dynamic work schedule to meet business needs.
- Education
- Minimum bachelor’s degree in engineering or related field or equivalent experience.
Additional Information
- 20% travel (domestic and International)
- This is a permanent full-time position
- 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.