A global life sciences company in Tralee, Ireland is seeking a Technical Associate to perform maintenance on aseptic fill-finish equipment. The role involves troubleshooting various systems and ensuring reliable operation in cleanroom environments. Candidates should have a Level 6 qualification in Mechanical or Electrical fields, and experience in pharmaceutical settings is preferred. This position offers a comprehensive benefits package and emphasizes innovation and patient impact. #J-18808-Ljbffr
Validation Lead 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. 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 Lead the daily operations of the Validation function, managing Validation Engineers (staff and outsourced providers), coordinating activities, and improving operational efficiency. Ensure facilities, utilities, equipment, computerized systems, manufacturing processes, cleaning procedures, analytical methods, and aseptic operations perform as intended and reliably produce safe, effective, and compliant biopharmaceutical products. Provide strategic leadership across the validation lifecycle-planning, execution, review, approval, and maintenance-aligned with GMP, data integrity principles, and risk-based methodologies. Own the Site Validation Master Plan (VMP), champion cross-functional governance, and drive continuous improvement to maintain a validated state. Role and Responsibilities Lead and develop the Validation team; foster an engaged, psychologically safe, high-performance culture aligned with Astellas values. Ensure stable supply and delivery of departmental objectives; resolve issues, prioritise effectively, and drive continuous improvement via ambitious KPIs. Maintain compliance with GMP, GDP, environmental, safety, and governance requirements; ensure audit readiness and robust data integrity. Contribute to site and global strategy; deliver strategic projects on time and within budget while anticipating future trends and skill needs. Lead implementation of new products, technologies, systems, and procedures; ensure compliant change management and effective knowledge transfer. Build strong cross-functional and global partnerships; support business continuity, mitigate risks, and deputise for site leaders as required. Required Qualifications Bachelor's degree (or equivalent) in an Engineering or Scientific discipline, or proven relevant in-depth experience. Preferred Qualifications Extensive experience in a similar role with strong technical competence and validation leadership capability (cGMP start‑up experience advantageous). Proven ability to progress complex technical projects, support commissioning/maintenance of cGMP manufacturing, and manage multiple priorities. Excellent organisational, interpersonal, verbal, and written communication skills; able to work independently and collaboratively; open to new ideas. Our Organizational Values and Behaviors Impact Innovation Integrity One Astellas Accountability Courage Sense of Urgency Outcome Focus 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. #J-18808-Ljbffr
A leading pharmaceutical company in Ireland is seeking a Sustainability Engineer to lead initiatives for sustainability-driven systems and ensure environmental compliance. The role requires a third-level qualification in Engineering or Environmental Science along with experience in sustainability leadership within manufacturing or pharma. Responsibilities include overseeing the Sustainability Management System and monitoring environmental performance through KPIs. The position is 100% onsite in Tralee and offers opportunities for global collaboration and personal growth. #J-18808-Ljbffr
A leading pharmaceutical company is seeking a Critical Utilities Engineer in Tralee, Ireland. This role involves ensuring the operation and regulatory compliance of utility systems essential for manufacturing. Candidates should have a third-level engineering qualification and experience in GMP settings. Responsibilities include developing maintenance procedures and acting as a Subject Matter Expert. The company offers a collaborative environment focused on innovative patient care and professional growth. #J-18808-Ljbffr
Sustainability Engineer We are seeking individuals who thrive in dynamic environments, embrace new ideas and are committed to making a meaningful impact. About Astellas At Astellas we are making treatments that matter to people. We are tackling the toughest health challenges, placing the patient at the heart of everything we do. Through our global vision for Patient Centricity, we integrate the patient experience into our everyday working practices. We have developed groundbreaking medicines in immunology, oncology and urology, improving and saving the lives of patients worldwide. Location and Working Environment This position is 100% onsite in Tralee, Ireland. Purpose & Scope Lead the operation, maintenance, regulatory compliance, procurement, and continuous improvement of sustainability-driven systems and equipment within the facility. Oversee the implementation and compliance of the Environmental and Sustainability Management System, including ongoing efficiency reviews of facility operations, and sustainable design assessments for all new equipment, processes, and projects. Role and Responsibilities Develop and implement operational and maintenance procedures aligned with sustainability best practices, energy efficiency, environmental compliance, and ISO 14001/ISO 50001 standards. Act as a subject matter expert on environmental and energy systems, troubleshooting sustainability-related issues and supporting change control, commissioning, and qualification activities. Monitor environmental performance by compiling sustainability KPIs (e.g., carbon footprint, energy, water, waste, recycling) and generating reports for audits, regulatory submissions, and management review. Maintain and continually improve the Sustainability & Energy Management System through internal audits, non-conformance management, accurate record keeping, and regulatory monitoring. Support and lead sustainability initiatives and facility projects, ensuring environmental impact considerations, sustainable design principles, and resource efficiency are integrated into project planning and execution. Communicate sustainability performance and risks to leadership, promote sustainability awareness across the organization, and contribute insights during cross-functional meetings and strategic discussions. Required Qualifications Third level qualification in Engineering or Environmental Science, Sustainability, or related discipline, or extensive related proven experience in the required areas. Essential Knowledge & Experience Experience in manufacturing, pharmaceutical, or industrial engineering with sustainability leadership responsibilities, including ISO 14001 and ISO 50001 implementation. Strong knowledge of environmental control systems, waste reduction processes, renewable energy integration, and sustainability reporting, with experience in facilities/utilities or Energy Management Systems within a GMP environment considered an advantage. Proven project management, analytical, and problem‑solving skills, with a proactive and solutions‑focused approach and strong documentation practices. What awaits you at Astellas? Global collaboration and connection with like-minded life science leaders. Real‑world patient impact through transformative therapies. Relentless innovation at the forefront of scientific advancement. A culture of growth that supports your development and ambitions. Our Organizational Values and Behaviors Impact Innovation Integrity One Astellas Accountability Courage Sense of Urgency Outcome Focus Benefits Career | Astellas 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. #J-18808-Ljbffr
Critical Utilities Engineer About Astellas At Astellas we are making treatments that matter to people. We are tackling the toughest health challenges, placing the patient at the heart of everything we do. Through our global vision for Patient Centricity, we integrate the patient experience into our everyday working practices. We have developed ground breaking medicines in immunology, oncology and urology, improving and saving the lives of patients worldwide. Learn Are you driven to make a real difference in the lives of patients? We are seeking individuals who thrive in dynamic environments, embrace new ideas and are committed to making a meaningful impact. Location and Working Environment This position is 100% onsite in Tralee, Ireland. Purpose & Scope The Critical Utilities Engineer is responsible for the operation, maintenance, regulatory compliance, procurement, and continuous improvement of all critical utility systems and equipment. This role ensures reliable supply and operational performance of utilities in support of manufacturing, laboratory, and facility needs, while maintaining compliance with GMP standards and other relevant regulations. Key systems include HVAC, purified water, clean steam, WFI, compressed air, process air, chilled water, process gases, and other building utility services essential to production and quality. Role and Responsibilities Develop, implement, and maintain operational and maintenance procedures for critical utility systems to ensure reliability, efficiency, and regulatory compliance. Act as Subject Matter Expert (SME) for GMP and non‑GMP utilities, troubleshooting issues, ensuring system readiness, and supporting change control and qualification activities. Monitor system performance and quality compliance, investigate non‑conformances, implement CAPA, and generate technical reports for audits, regulatory submissions, and product quality reviews. Conduct internal audits and maintain documentation, maintenance logs, and procedures in line with GMP, safety, and regulatory requirements. Drive continuous improvement by tracking KPIs (e.g., uptime, energy use, efficiency), promoting utility management standards, and maintaining awareness of relevant regulations and best practices. Provide technical leadership and support for facility and engineering projects involving utilities, including shutdown planning, system design input, and regular reporting of risks, performance, and resource needs. Required Qualifications Third level qualification in Engineering (Mechanical, Electrical, Chemical, or related field) or proven relevant experience. Essential Knowledge & Experience Experience in pharmaceutical, biotech, or industrial environments working with critical utility and facilities systems in GMP settings. Strong technical knowledge of utility control systems, automation, environmental controls, and energy optimisation/sustainability practices. Excellent documentation, communication, and supervisory skills with a proactive, flexible, and self‑motivated approach. What awaits you at Astellas? Global collaboration and connection with like minded life science leaders. Real world patient impact through transformative therapies. Relentless innovation at the forefront of scientific advancement. A culture of growth that supports your development and ambitions. Our Organizational Values and Behaviors Impact Innovation Integrity One Astellas Accountability Courage Sense of Urgency Outcome Focus Benefits Career | Astellas 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. #J-18808-Ljbffr
A global life sciences company is seeking a Validation Lead in Tralee, Ireland. The role involves leading daily operations of the Validation function and managing a team. Ideal candidates will have a bachelor's degree in engineering or a scientific discipline, extensive validation experience, and excellent organizational and communication skills. The position requires ensuring compliance with GMP and driving continuous improvement initiatives. This position is fully onsite and offers a chance to make a significant impact in the biopharmaceutical industry. #J-18808-Ljbffr
A global life sciences company is seeking a Facilities Engineer in Tralee, Ireland. This role involves ensuring the operation and maintenance of Facilities systems, leading energy management initiatives, and ensuring regulatory compliance. Candidates should have a relevant engineering qualification, experience in pharmaceutical or industrial processes, and strong knowledge of GMP and control systems. This is a 100% onsite position, emphasizing collaboration and continuous improvement. #J-18808-Ljbffr
Facilities 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 . Location and Working Environment This position is 100% onsite in Tralee, Ireland. Purpose & Scope Ensure the operation, maintenance, regulatory compliance, procurement, and continuous improvement of all Facilities systems and equipment. Lead energy management reviews and provide input into the design and implementation of new systems, equipment and processes, ensuring alignment with best practices, efficiency and sustainability. Role and Responsibilities Develop and implement operational and maintenance procedures ensuring compliance and best practices. Continuously improve Facilities and Energy Management Systems for optimal efficiency. Act as SME owner for GMP and non-GMP systems. Troubleshoot equipment issues and support regulatory submissions with data and reports. Lead or participate in cross-functional teams; support change control, commissioning and qualification. Maintain and enhance the Energy Management System in line with energy policies and regulations. Required Qualifications Third-level qualification in Engineering or Science, or equivalent relevant experience. Experience in Pharmaceutical, Industrial, or Semiconductor processes. Strong knowledge of GMP, validation, HVAC, Clean Utilities and control systems. Familiarity with H&S, Fire Systems and Environmental Controls. Strong communication, documentation and supervisory skills. Preferred Qualifications Experience with Energy Management Systems and regulatory compliance. Strong organisational, problem-solving and planning skills with a proactive approach. What awaits you at Astellas? Global collaboration across a connected life-science community. Meaningful patient impact through transformative therapies. Relentless innovation at the forefront of science. A growth-minded culture supporting your development. Our Organizational Values and Behaviors Impact Innovation Integrity One Astellas Accountability Courage Sense of Urgency Outcome Focus 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. #J-18808-Ljbffr
Learning & Development Specialist 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 welcome individuals who thrive in collaborative environments, embrace continuous improvement and contribute to strong compliance culture. Location and Working Environment This position is 100% onsite in Tralee, Ireland. Purpose & Scope Support training compliance within an aseptic fill-finish GMP environment, ensuring alignment with regulatory expectations and internal policies. Role and Responsibilities Identify and implement training plans for compliance and capability development. Prepare training materials including curricula and e-learning modules. Ensure regulatory and procedural compliance in training activities. Track and report training metrics and readiness for audits. Support commissioning and qualification training needs. Provide regular updates to operational leadership and identify gaps. Required Qualifications Third-level qualification in Engineering/Science or equivalent related experience. Experience in GMP pharmaceutical manufacturing and training delivery. Preferred Qualifications Experience in aseptic operations, instructional design and audit readiness. Strong interpersonal, communication and planning skills. What awaits you at Astellas? Collaboration across a global life-science network. Opportunities to improve patient experiences through capability development. An innovation-focused environment. Supportive culture fostering continuous growth. Our Organizational Values and Behaviors Impact Innovation Integrity One Astellas Accountability Courage Sense of Urgency Outcome Focus Benefits Learn more: 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. Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address. If you encounter a fake profile or anything suspicious, report it promptly to LinkedIn's support team through LinkedIn Help. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register. #J-18808-Ljbffr
