Biotech Associate - 23 Month Fixed Term Contract 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 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 Execute activities to produce pharmaceutical drug products in a cleanroom environment, including aseptic filling and lyophilisation processes, ensuring compliance with all regulatory and site requirements. Support operational effectiveness, contribute to continuous improvement initiatives, and provide value added input across manufacturing operations. Role And Responsibilities Perform cleanroom manufacturing operations to required safety, quality and efficiency standards. Ensure compliance with cGMP, ISO 14001, Health & Safety and site procedures. Accurately input and extract data from computerized systems while maintaining data integrity. Troubleshoot equipment and material issues and participate in investigations. Complete required training and contribute to a culture of strong teamwork and safety. Support operational projects, validation and new product introductions. Required Qualifications Minimum Level 6 qualification in Engineering/Science or equivalent. Preferred Qualifications Experience in cGMP environments, aseptic fill finish operations and audits. Strong analytical skills with experience in Lean/Six Sigma (Yellow Belt or higher advantageous). Excellent communication, interpersonal and organizational skills. Ability to work independently or as part of a team, adaptable to changing priorities. 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 and growth support in a global, collaborative environment. Opportunity to impact patient lives through transformative therapies. Exposure to cutting‑edge science and innovation. Inclusive workplace with emphasis on integrity, accountability, and urgency. 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
Astellas Pharma seeks a Biotech Associate for a 23-month fixed-term contract in Tralee, Ireland. The role entails performing cleanroom manufacturing operations, adhering to safety and quality standards, and supporting operational effectiveness in a regulated environment. Candidates should have a Level 6 qualification in Engineering or Science, with preferred experience in cGMP settings and strong analytical skills. The position offers career growth in a collaborative, innovation-driven atmosphere focused on impactful patient therapies. #J-18808-Ljbffr
Quality Assurance Systems Specialist – 6 month FTC 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 more at Astellas.com. 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 based in the Kerry (Killorglin) Plant and will require onsite working. Working Hours Full time Purpose and Scope Based in our Kerry Plant (Killorglin) and reporting to the QA Systems Co‑Ordinator, the QA Specialist will primarily be responsible for supporting the issuance and control of production batch records, ensuring compliance with GMP requirements and site procedures. The position will also be responsible for supporting compliance with cGMP regulations, as well as the development and maintenance of the Quality Management System. The position is therefore responsible for assisting with the ongoing development, implementation, and maintenance of cGMP compliance. Role and Responsibilities Primary Responsibilities Support the issuance and control of production batch records in accordance with GMP and site procedures. Act as a key point of contact, liaising closely with Production and Quality Assurance personnel to ensure batch record and documentation requests are completed accurately and on time. Ensuring data integrity and compliance with regulatory requirements. Secondary Responsibilities Foster a culture of cGMP & Quality awareness across management and staff. Ensure site-wide compliance with cGMPs, including data integrity. Support inspection readiness through timely and compliant progression of eQMS records. Provide real‑time support for manufacturing, QC, and operations: including non‑conformance management, root cause investigations, risk assessments, CAPA and effectiveness checks. Assist with internal/external audits and regulatory/customer inspections. Coordinate the customer complaints process, including investigation progression and final reports. Support supplier qualification process and related risk management. Review and QA approve SOPs/ controlled documents for QA, plant, warehouse, and QC; ensuring cGMP compliance. Compilation of inspection readiness metrics. Support the Product Quality Review process. QA representative on major projects within AICL (KP), including LEAN/ OPEX activities. Other support areas include but are not limited to: quality investigations, TrackWise, ADMS authoring, training of new personnel and batch review activity, as assigned. Required Qualifications Third level qualification in Science or Engineering discipline, preferably with experience of working in a GMP environment or equivalent. Preferred Qualifications Excellent communication and collaboration skills. Knowledge of regulatory requirements related to pharmaceutical manufacture. Exceptional attention to detail and organisational skills. Proficiency in Microsoft Office Suite, including MS Excel. Ability to manage multiple tasks and deadlines effectively. Benefits Global collaboration: Work within a connected global community dedicated to improving patient lives. Real world patient impact: Contribute to life changing therapies that help people worldwide. Relentless innovation: Be part of an organisation pushing scientific and operational boundaries. A Culture of Growth: Thrive in a supportive workplace that values development and progression. Organisational Values and Behaviours 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
Astellas Pharma is seeking a Quality Assurance Systems Specialist for a 6-month FTC at their Kerry Plant in Killorglin, Ireland. The role involves supporting the issuance and control of production batch records, ensuring compliance with GMP requirements, and assisting with the Quality Management System. Candidates should have a third-level qualification in Science or Engineering and preferably experience in a GMP environment. This position requires onsite work, and ideal candidates will demonstrate strong communication skills and attention to detail. #J-18808-Ljbffr
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 more at Astellas.com. Graduate Onsite Support Engineer (2 year FTC) Location: Kerry, Ireland. This is a 2‑year FTC starting September 2026. The position is 100% onsite and may require occasional evening or weekend work. Purpose And Scope The On‑Site Support Engineer is responsible for providing comprehensive onsite technology support and services to ensure optimal performance of all IT infrastructure and systems at assigned sites. This role involves installation, maintenance, troubleshooting, and repair of hardware and software, as well as providing excellent customer service to resolve technical issues efficiently. Role and Responsibilities Learn and work with IT technical support for hardware, software, and networking issues. Understand routine maintenance and upgrades on IT systems and equipment. Diagnose and provide technical information on computers, servers, networks, and other technological components. Follow onsite team guidance and perform hardware repairs, replacements, and system updates as needed. Customer Service Engage with clients to address technological concerns promptly and professionally. Communicate effectively to understand client requirements. Train and support end‑users on technology usage and best practices. Documentation And Reporting Document and maintain accurate records of all onsite activities, including service requests, incident reports, and maintenance logs. Document configurations, procedures, and troubleshooting steps for future reference. Provide regular status updates and reports to management. Compliance And Security Ensure compliance with company policies, industry standards, and regulatory requirements. Follow company security protocols to protect client data and IT infrastructure. Team Collaboration Work as one team across sites to share knowledge and improve processes. Collaborate with on‑site support teams such as Lab, AV, and with remote teams (Infrastructure, Security) to provide the best possible service. Act as the hands and eyes for remote teams when required (Network, Server, Security). Required Qualifications Minimum degree level qualification in IT or an equivalent field. Minimum graduate or recent graduate status, with degree completed before September 2026. Preferred Qualifications & Skills Good knowledge of computer hardware, software, networking, and operating systems. Strong troubleshooting and repair skills for IT equipment and systems. Excellent customer service and communication skills to interact with users. Ability to work independently and manage multiple tasks effectively. Fluent in written and verbal business English. Valid driver’s license and willingness to travel to other local sites as required. What Awaits You at Astellas Global collaboration within a connected community dedicated to improving patient lives. Contributing to life‑changing therapies with real‑world patient impact. Engaging in relentless innovation within a forward‑thinking company. Experiencing a culture of growth and support that fosters development and progression. Our Organisational Values and Behaviours Impact Innovation Integrity One Astellas Accountability Courage Sense of Urgency Outcome Focus Benefits 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. #J-18808-Ljbffr
Astellas Pharma is seeking a Graduate Onsite Support Engineer for a 2-year fixed-term contract starting September 2026 in Kerry, Ireland. This role involves providing comprehensive onsite technology support for IT infrastructure, including installation and troubleshooting of hardware and software. The ideal candidate should have a degree in IT or a related field, and possess strong customer service skills. This position is 100% onsite and may require occasional evening or weekend work. #J-18808-Ljbffr
Engineering Production Technician, 12-month FTC Astellas is a global life sciences company committed to turning innovative science into value for patients. Location and Working Environment This position is onsite at AICL Kerry Plant, Ireland. Working Hours This position operates on a weekly rotation of day and evening shifts. Purpose and Scope Capsule Production of products to GMP standards. Member of a Capsules team. Role And Responsibilities Provide all manner of Engineering support to the Production group to ensure all shop floor schedules are met. Ensure all machines are correctly maintained and minimize downtime. Responsibility for all aspects of maintenance for production related equipment, typically but not limited to planned maintenance, spare parts ordering, store organization, set-up/preparation of equipment for production. Required Qualifications Certificate/Diploma in an Engineering discipline, or a trade qualification in an engineering discipline, or extensive engineering experience. Excellent communication skills. Strong focus on the importance of quality. Strong attention to detail. Good computer skills and technical ability. Ability to work as part of a flexible team. Preferred Qualifications Mechanical and electrical experience or educational background desirable. Mechatronics qualification desirable. What awaits you at Astellas? Global collaboration: Work within a connected global community dedicated to improving patient lives. Real-world patient impact: Contribute to life-changing therapies that make a difference worldwide. Relentless innovation: Join a company pushing scientific boundaries. A Culture of Growth: Thrive in a supportive environment that fosters development and progression. Our Organisational Values and Behaviours Impact Innovation Integrity One Astellas Accountability Courage Sense of Urgency Outcome Focus Benefits 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. #J-18808-Ljbffr
A leading pharmaceutical company is seeking a Facilities Engineer to maintain and improve all Facilities systems and equipment onsite in Tralee, Ireland. The role requires a third-level qualification in Engineering or Science and experience in the pharmaceutical or industrial sectors. Responsibilities include ensuring compliance with GMP standards, leading energy management reviews, and participating in cross-functional teams. This position offers a dynamic working environment with a commitment to innovation and patient impact. #J-18808-Ljbffr
Facilities Engineer We welcome individuals who thrive in dynamic environments, embrace new ideas, and are committed to making meaningful impact. 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. Benefits 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. 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
Overview Graduate Systems Engineer About Astellas At Astellas we are making treatments that matter to people. We tackle 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. 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, extending and saving lives of cancer patients, making transplantation possible and improving the quality of life for people with underserved needs. We take a patient-focused approach that helps 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. About This Job As a Graduate Systems Engineer, you will work within a systems team overseeing the day-to-day operations of autonomous systems, providing crucial support for Operations and Quality automation systems (Levels 1 to 3). The systems team is responsible for the end-to-end ownership of the design, development, configuration, management, compliance, integration, and continuous improvement of applications, ensuring the smooth and efficient execution of operations and quality processes. Additionally, you will serve as the primary custodian and owner of relevant systems within the site. These systems include, but are not limited to, DCS, PLC/SCADA, MES, LIMS, CMX, and Empower. Over time, team members will gain expertise in and provide support for all these systems. You will be part of an inclusive team that works to develop innovative therapies for patients. Key Activities For This Role Design reliable and robust systems to meet business and process requirements for Process Control Systems (DCS and PLC/SCADA) and vendor-packaged equipment, ensuring integration with upstream and downstream systems like Filling Line, Utilities, MES, and Data Historian. Create, review, and approve automation and operational technology deliverables, including schedules, user requirements, design documents, and IQ/OQ/FAT protocols for L2 systems, ranging from standalone lab instruments to aseptic filling lines. Ensure the administration of cGMP-computerized systems maintains data integrity, including conducting periodic reviews and supporting relevant procedures. Diagnose and resolve technical problems through proactive problem-solving efforts, providing both short-term and long-term solutions for system issues. Ensure compliance with cGMP regulations, Health & Safety legislation, and other relevant standards while supporting the administration and maintenance of systems and technologies. Support system qualification and validation activities by attending and contributing to ensure alignment with procedural requirements. Essential Knowledge & Experience Theoretical knowledge of Process Control Systems (DCS and PLC/SCADA) and vendor packaged equipment including integration to both upstream and downstream systems such as Filling Line, Utilities, MES, Data Historian, etc. Good interpersonal and communication skills. Good organisational and planning skills. Ability to work on one’s own initiative and take a proactive approach to all aspects of the role is essential. Good documentation practices. A very flexible approach to work and practices/procedures is required to ensure smooth operation of the department. Education/Qualifications Bachelor’s degree in technology or computer science or proven relevant in-depth experience. This is a 2-year, fixed-term contract. This position is on-site based in Tralee plant / County Kerry, Ireland. Candidates must be located within a commutable distance of the office. What We Offer A challenging and diversified job in an international setting. Opportunity and support for continuous development. Inspiring work climate. 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. © Astellas. EEO statement retained as part of the job description. #J-18808-Ljbffr
