Manufacturing Engineer

7 days ago

Tralee, Ireland Astellas Pharma Full time

Overview
Description
Manufacturing Engineer
About Astellas
At Astellas we are making treatments that matter to people.
We are tackling the toughest health challenges putting the patient at the heart of every move we make.
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 have developed ground-breaking, innovative medicines in immunology, oncology and urology.
Our medicines are extending and saving the lives of cancer patients, making transplantation possible and improving the quality of life for those living with conditions where needs are often overlooked.
We take a patient-focused approach, that allows us to convert brilliant early science into treatments and solutions that directly improve and save patients' lives.
From lab to clinic to patient, we focus on the most promising science, empower the best talent to pursue it, and develop life-changing solutions alongside the best partners.
Role
The Opportunity
As a 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).
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 experience.
Additional Information
This role requires approximately 20% travel, both domestic and international.
This is a permanent, full-time position
This 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.
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