Lyophilisation Lead Engineer About Astellas Astellas is a global life sciences company committed to turning innovative science into VALUE for patients.
We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health.
Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need.
Learn. Are you driven to make a real difference in the lives of patients? We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks.
People who act with unwavering integrity and are deeply committed to making a tangible impact.
Location and Working Environment This position is 100% onsite in Tralee, Ireland.
Purpose & Scope Provide technical support to lyophilisation operations, engineering, and control systems to ensure efficient, compliant operations.
Ensure GMP compliance and data integrity of computerised systems.
Lead deviations, investigations, CAPAs, and root cause analysis.
Drive continuous improvement using Lean Six Sigma.
Manage projects, technology transfer, commissioning, and cross-functional collaboration.
Apply strong analytical and automation/SCADA/PAT expertise.
Role and Responsibilities Support lyophilisation operations and ensure achievement of production and project schedules.
Maintain compliance with c GMP, ISO 14001, EMAS, Health & Safety, and Environmental legislation.
Train and develop staff; maintain SOPs and documentation.
Support Operational Excellence initiatives and promote strong teamwork and safety culture.
Required Qualifications Bachelor's or Master's degree in Chemical Engineering, Pharmaceutical Sciences, Bioprocess Engineering, Biotechnology, or related field, or extensive relevant experience.
Preferred Qualifications Experience in lyophilisation process development or operations (e.g., Lyomax).
Expertise in aseptic vial lyophilisation, CIP/SIP/FIT, process instrumentation, control systems, qualification, and validation.
Strong organisational, interpersonal, verbal, and written communication skills.
Ability to work independently or as part of a team.
What awaits you at Astellas? Global collaboration.
Real-world patient impact.
Relentless innovation.
A culture of growth.
Our Organizational Values and Behaviors Impact Innovation Integrity One Astellas Accountability Courage Sense of Urgency Outcome Focus Benefits Careers | Astellas We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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