Senior Manufacturing Engineer
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:
You will install, maintain, and troubleshoot equipment used in biologics manufacturing while ensuring compliance with regulatory standards (e.g., FDA, EMA) and GMP. You'll implement corrective actions to address deviations and improve product quality, collaborating with Validation Engineers to develop and execute validation protocols. Your role will also involve performing data analysis to ensure manufacturing and test readiness, contributing to lean manufacturing initiatives, and identifying areas for process improvement. Working closely with global product design, Quality, Operations, and Engineering teams, you'll align manufacturing processes with product development goals, becoming an expert in Aseptic Filling and Lyophilisation, and leading cross-functional meetings to optimize machine operations.
Responsibilities:
Responsibilities and Complexity: This position involves significant responsibility, decision-making, and leadership including mentoring of others and contributing to strategic planning.
Impact and Influence: Drives organizational success, influences company-wide decisions, and shapes long-term strategies.
Expertise and Depth of Knowledge: Deep expertise, recognized as subject matter expert.
Leadership and Decision-Making: Help set departmental direction. Help make strategic decisions, and guide others.
Project Complexity: Oversees large-scale, complex process improvement initiatives.
Collaboration and Cross-Functional Skills: Build relationships at all levels, both internally and externally.
- Provide daily technical support and troubleshooting in collaboration with Operations and Engineering teams, ensuring effective equipment and material standards.
- Support continuous improvement efforts through Kaizen, Lean/Six Sigma, and problem-solving methodologies to enhance line performance and reduce technical downtime.
- Develop and implement systems for monitoring and analyzing equipment performance, initiating actions to maximize reliability and availability.
- Contribute to strategic development, including the creation of a development plan and involvement in the annual and investment budget planning.
- Ensure quality compliance by maintaining effective SOPs, liaising with QA/QC, and establishing KPIs for quality performance and audit preparation.
- Lead and coordinate performance improvement projects, manage project teams, and provide technical support for product investigations and related reports.
Essential Knowledge & Experience:
- Align daily work and decision-making with internal customer and external patient needs, maintaining effective relationships to support patients.
- Act with integrity, taking responsibility for actions that benefit patients and society.
- Contribute to a diverse, inclusive culture, respecting and adapting to cultural differences, and building trust in global teams.
- Continuously seek self-improvement through feedback and a Growth Mindset, applying it to maximize positive outcomes for patients and Astellas.
- Challenge current processes and suggest innovations driven by scientific possibilities and patient needs, fostering a flexible, change-ready environment.
- Set and achieve ambitious objectives that contribute to team and organizational goals, ensuring timely delivery with integrity and collaboration.
Education:
- Minimum bachelor’s degree in engineering or related field or equivalent.
Additional information:
- 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.