Manufacturing Engineer Building your career at Astellas continues to offer inspiring challenges and a chance to make your mark in doing good for others.
Our open and progressive culture is what makes us Astellas.
It is a culture of doing good for others and contributing to a sustainable society.
Reporting directly to the Operations Engineering Lead, 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).
Join us in this dynamic role and contribute to our team's success at Astellas.
Apply now to be part of this exciting journey.
About This Job Daily line technical support and troubleshooting with the Operations and Engineering Teams.
Support implementation of effective guides and procedures for: Equipment Operation, troubleshooting etc.
Understand and look to optimise equipment design principles.
Provide technical training and associated documentation.
Key technical expert in your field and in technical problem-solving practices in general.
Implement corrective actions to address deviations and improve overall product quality.
Collaborate with Validation Engineers to develop and execute validation protocols.
Perform data analysis to ensure manufacturing and test readiness.
Contribute to lean manufacturing initiatives to optimize efficiency.
Identify areas for process improvement and implement solutions.
Work closely with global product design teams, Quality, Operations and Engineering teams to align manufacturing processes with product development goals.
Become process experts on Aseptic Filling and Lyophilisation.
Participate and lead cross-functional meetings to optimal machine operation.
Essential Knowledge & Experience Minimum bachelor's degree in engineering or related field or equivalent experience.
Industry experience in Biologics/Pharmaceutical manufacturing or other relevant GMP environment.
Understanding of biologics drug substance manufacturing processes, with a strong focus aseptic filling and lyophilization a distinct advantage.
Excels in a fast-paced team environment and completes assigned work in timely fashion.
Strong interpersonal skills, highly collaborative within a multi-disciplinary team and contributes to a supportive and positive work environment.
This role is required to support GMP Operations.
The work schedule is subject to change to support business operations.
Preferred Knowledge & Experience Direct experience in drug manufacturing Experience with Lean Manufacturing techniques, statistical analysis and data science techniques and implementation an advantage.
Additional information 20% travel (domestic and International) This is a permanent role.
Based at manufacturing plant Tralee.
This role is onsite.
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.
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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