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 JobDaily 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 optimize 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 Lyophilization.Participate and lead cross-functional meetings to optimize machine operation.Minimum RequirementsMinimum 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 on aseptic filling and lyophilization a distinct advantage.Excels in a fast-paced team environment and completes assigned work in a 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 & ExperienceDirect experience in drug manufacturing.Experience with Lean Manufacturing techniques, statistical analysis, and data science techniques and implementation an advantage.Additional Information20% 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.
We are proud to offer an inclusive and respectful working environment that fosters collaboration and ownership.
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. #IJA
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