Description Project Lead Engineer, 23-month FTC 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. The Opportunity The Project Lead Engineer is responsible for planning, executing, and delivering key projects that support biopharmaceutical manufacturing, facility upgrades, technology transfers, and process improvements. This role ensures that projects meet regulatory, safety, quality, and business requirements while coordinating cross‑functional teams and external vendors. Responsibilities Project Management: Lead end‑to‑end engineering projects, develop scopes, schedules, budgets, risk assessments, and deliver controlled handovers and closeouts while presenting progress to stakeholders. Technical Leadership: Provide engineering expertise across equipment, utilities, automation, and process systems; develop URS/design documents; review drawings, FAT/SAT protocols, and support commissioning, qualification, and process optimization. Cross‑Functional & Vendor Coordination: Collaborate with QA, Validation, Manufacturing, Supply Chain, EHS, and external contractors/OEMs; facilitate design reviews, hazard assessments, change controls, and technical meetings. Compliance & Quality Assurance: Ensure all deliverables meet GMP/GDP, FDA, EMA, ICH, and internal standards; support IQ/OQ/PQ and FAT/SAT activities; maintain documentation for audits and regulatory needs; promote strong safety culture. Budgeting & Cost Control: Prepare capital justifications, manage CAPEX budgets, track expenditures, control change orders, and support procurement, vendor selection, and contract negotiations. Risk & Performance Management: Identify and mitigate project risks, maintain documentation and progress tracking tools, and evaluate project outcomes to drive continuous improvement. Essential Knowledge & Experience Strong knowledge of GMP, validation, and pharmaceutical manufacturing, with proficiency in project management tools (e.g., MS Project, Primavera) and strong analytical, organizational, and troubleshooting skills. Excellent leadership, communication, stakeholder management, and people‑management abilities, with proven capability to manage multiple projects in a fast‑paced, regulated setting. Education Bachelor’s degree in Engineering or related field, or significant experience managing pharmaceutical engineering projects, equipment vendors, and cross‑functional teams in a GMP‑regulated environment. Additional Information This is a 23 month FTC - full‑time position Position is based in Tralee – Ireland This position requires you to be 100% on site / in the office Willingness to undertake international travel 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. #J-18808-Ljbffr
Description Business Systems Associate 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. The Opportunity Will participate in some elements of documentation control role for GMP/Non GMP/ EDMS (Electronic Document Management System) of controlled documentation (on‑site and off‑site) including issuance, storage, archiving, implementation of document retention policy and document retrieval when requested. Contact person for executing SAP functions such as raising PO, review/approval of invoices and set up of new vendors on SAP as required, processing travel requests for personnel, control of consumable and general budgets, and for implementing systems in the plants to paperless. Support the Systems group with various software packages in particular managing access requests following through to gradually developing knowledge and being trained on onsite computerised systems such as MES, PCS, BMS, SAP. Key Responsibilities Document & Records Management: Support full lifecycle management of controlled documents (creation, issuance, storage, archiving, retention, retrieval) and ensure compliance with regulatory and internal requirements. System Administration & Access Control: Facilitate user access requests and removals for electronic systems, provide backup EDMS support, and manage RIMs activities. Administrative & SAP Support: Execute SAP tasks (PO creation, invoice review/approval, vendor setup), process travel requests, and manage consumable and general budgets. Procedure & Training Support: Prepare procedures and reports, facilitate training, and assist departments with system setup and ongoing operational needs. Systems Knowledge & Integration: Develop proficiency in MES, PCS, BMS, SAP, and other computerized systems, supporting implementation and business‑as‑usual activities. Operational Excellence & Process Improvement: Contribute to site Operational Excellence initiatives and drive continuous improvement, including transitioning manual processes to paperless systems. Education B.S. in Business/Systems discipline 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. 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. #J-18808-Ljbffr
Description Supply Chain Partner 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. The Opportunity Professional Supply Chain and Logistics Partner, with knowledge and experience in the end to end supply chain operations in areas such as buying, planning, scheduling, and strategic planning. The Supply Chain & Logistics Partner should have expertise in SAP or equivalent ERP system. The ideal candidate will be responsible for strategizing, co‑ordinating and optimizing our supply chain processes, ensuring the timely procurement of materials, maintaining efficient production schedules and inventory management within a GMP pharmaceutical environment. Key Responsibilities Strategic Leadership & Decision-Making: Shapes departmental and organizational direction through strategic planning, budgeting, investment planning, and cross‑functional influence; recognized as a subject matter expert guiding large‑scale initiatives. End-to-End Supply Chain & Vendor Management: Leads supply chain strategy, vendor selection, negotiations, performance management, risk mitigation, and development of strong supplier partnerships aligned with business objectives. Planning, Scheduling & Inventory Control: Oversees production scheduling, demand alignment, and inventory optimization in coordination with production, engineering, and quality teams. Process Optimization, Technology & Data-Driven Improvement: Enhances efficiency through SAP/ERP utilization, KPI tracking, analytics, digital transformation, automation, and continuous improvement initiatives. Compliance, Quality & Documentation Excellence: Ensures adherence to GMP/GDP/FDA/EMA and internal policies, maintains audit-ready documentation, manages deviations/CAPAs/change controls, and sustains robust SOPs and visual management systems. Collaboration, Innovation & Performance Culture: Builds strong internal/external relationships, drives innovation and change agility, communicates effectively, supports team accountability, and contributes to organizational results aligned with the Astellas Way. Essential Knowledge & Experience Extensive experience in supply chain operations. Proficiency in ERP systems and supply chain software (e.g., SAP). Excellent analytical, problem‑solving, and organizational skills. Strong leadership and communication abilities. Strong negotiation, communication, and interpersonal skills Education Bachelor’s degree in Supply Chain, Logistics, Business Administration, or related field, with extensive experience in GMP-regulated pharmaceutical or other regulated supply chain environments. 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. Willingness to undertake international travel. 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. #J-18808-Ljbffr
A global pharmaceutical company in Tralee is seeking a Business Systems Associate to manage document control processes and provide SAP support. The role involves overseeing user access, executing administrative tasks, and promoting operational excellence. The ideal candidate holds a B.S. in Business/Systems discipline and has experience with electronic documentation systems. This is a permanent, full-time position requiring 100% on-site presence. #J-18808-Ljbffr
Description Process 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. The Opportunity Reporting directly to the Operations Engineering Lead, you will provide technical support to the Operations Department, including effective investigation and root cause analysis, as well as the implementation of corrective actions to ensure efficient production operations and support manufacturing schedule adherence. You will also be responsible for ensuring that all of the above functions comply with internal and external regulatory, legislative, and statutory requirements. Responsibility Provision of technical support to the operational areas and engineering personnel in order that operations are conducted efficiently, and approved production and project schedules are achieved. Responsible for the DCS and other control systems in operational areas. Ensuring system compliance with all site standards and procedures. This includes maintaining a high level of system operational performance. Responsible for ensuring that the administration of GMP computerised systems in your remit is carried out in a manner which ensures the integrity of the data created, modified, or maintained on the systems. Lead proactive problem‑solving efforts and resolve process equipment issues, diagnose technical problems, and determine short‑term and long‑term solutions. Responsible for expediting CAPA implementation pertaining to Operations Department raised incidents/deviations in line with target completion dates. Manage and/or support activities to maximise value (e.g., increase revenue, reduce costs) such as (but not limited to) process optimisation, waste reduction/recycling, energy saving etc. Co‑ordinate continuous improvement activities in the area through the application of Lean Six Sigma. Lead CI forums to identify and review the progress of improvement initiatives to ensure benefits are realised. Report on area performance. Manage and/or support technology transfer for new technologies and processes, as required. Complete assigned LMS training items in line with target completion dates. Ensure compliance with relevant regulations and standards associated with cGMP, ISO 14001, EMAS, Health & Safety Legislation and Environmental Legislation, and all site standards, policies, and procedures. Support other sections to ensure such compliance. Education Minimum requirement: B.S. in Engineering, Chemical / Biochemical discipline or equivalent experience. Essential Knowledge & Experience Industry experience of successful delivery, preferably in a similar role. Technical proficiency, including broad understanding of filtration and purification technologies and processes, experience with process control systems, process instrumentation, equipment qualification, and process validation. Able to demonstrate previous experience of successfully progress projects independently, provide process engineering design, implementation/commissioning services and maintenance support of cGMP manufacturing. Able to demonstrate significant contributions on project. Proven analytical and problem‑solving skills including Lean Six Sigma proficiency to at least Yellow Belt level. Preferred Knowledge & Experience Direct experience in drug manufacturing. Experience in a cGMP start up environment. Experience of control systems (DCS, PLC) would be an advantage. Additional Information This role requires approximately 20% travel, both domestic and international. This is a permanent, full‑time position. This position is based at the manufacturing plant in Tralee, Ireland. This position requires you to be 100% on‑site. 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 biopharmaceutical company is seeking a Project Lead Engineer in Tralee, Ireland. This full-time position involves planning and executing projects in biopharmaceutical manufacturing while ensuring compliance with regulatory standards. The ideal candidate should have a degree in engineering, strong GMP knowledge, and proven project management skills. The role requires being on-site and may involve international travel. #J-18808-Ljbffr
A leading pharmaceutical company based in Tralee, Ireland is seeking a Process Engineer to provide technical support for production operations. This role involves ensuring compliance with cGMP standards, leading problem-solving efforts, and managing CAPA implementations. Candidates should possess a B.S. in Engineering or a related field and have industry experience in a similar role. This is a permanent, full-time position requiring 100% on-site presence with some travel involved. #J-18808-Ljbffr
A leading pharmaceutical company seeks a Supply Chain Partner for its Tralee location. The role requires extensive experience in supply chain operations and proficiency in SAP. Responsibilities include strategic leadership, vendor management, and compliance with regulatory standards. The perfect candidate will possess strong communication and analytical skills and be determined to optimize supply chain processes. This is a full-time position requiring on-site presence and the ability to travel internationally. #J-18808-Ljbffr
Description Chemistry Student – Kerry (June-Dec 26) 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. The Opportunity The main function of this position is helping/support to QC area(s). Key Activities For This Role Preparation of instruments for analysis, logbook records, and analytical glassware. Assistance with cleaning of glassware and disposal of completed analysis. Use of Word, Excel as required for reporting purposes. Participation in on‑going projects where required. All laboratory duties are required to be carried out in accordance with GMP and Safety procedures. Education Studying a 3rd level degree in Business, Scientific or Technical discipline. Additional Information This is a student placement position. Position is based in Kerry – Ireland. This position is fully onsite. Placement runs from June 2026 - December 2026. 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
Manufacturing Engineer 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. 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. #J-18808-Ljbffr
