About Astellas
At Astellas we are a progressive health partner, delivering value and outcomes where needed.
We pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.
We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage.
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 work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes.
Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care.
The Opportunity
As the Manufacturing Engineer, you will be 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).
Key Responsibilities:
- 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.
Additional information:
- This is a permanent full-time position
- 20% travel (domestic and International)
- 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.
#LI-Tralee
#LI-Onsite
#LI-MO1