A global biopharmaceutical company is seeking a Facilities Engineer in Tralee, Ireland, responsible for overseeing facilities operation, maintenance, and compliance. This role involves ensuring efficiency in energy management systems and compliance with regulatory standards. Ideal candidates will have a strong background in Engineering or Science, with experience in Pharmaceutical or Industrial processes. This is a permanent full-time position that requires being on-site 100%. #J-18808-Ljbffr
Description Quality 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 The role of the Quality Engineer will be to support the operations department to ensure compliance with GMP/GDP requirements for an Aseptic fill finish facility. Responsibilities include ensuring adherence to regulations and guidance, industry best practices, internal policies and procedures. This position works closely with Validation, Engineering, Facilities, Quality Control (QC) and other supporting functions to ensure compliance. Responsibilities Ensure compliance with internal/external regulatory, legislative, and statutory requirements, promoting awareness across Operations. Develop operational procedures for best practice and regulatory compliance; conduct risk assessments on processes and equipment. Generate reports and data for Annual Product Quality Reviews, Regulatory submissions, customer complaint investigations, and periodic reviews. Support internal/external audits, ensuring timely issue resolution, and raise/review non‑conformances. Provide quality technical support to Operations, including investigations, root cause analysis, and corrective actions to support production and schedule adherence. Support plant operational activities, Change Control, commissioning/qualification, and work closely with QA regulatory departments for submissions. Essential Knowledge & Experience Experience in Pharmaceutical/Med Tech processes, with expertise in GMP manufacturing, investigations, and risk assessments. Strong knowledge of audits, regulatory guidance, and Aseptic Fill Finish operations (advantageous). Excellent interpersonal, communication, organisational, and planning skills, with a proactive, self‑motivated approach. Strong documentation practices, problem‑solving abilities, and a flexible approach to ensure efficient departmental operations. Education Third level qualification in an Engineering or Science discipline, or extensive related proven experience in the required areas. 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 Facilities 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 As a Facilities Engineer, you will be responsible for the operation, maintenance, regulatory compliance, procurement, and continuous improvement of all Facilities systems and equipment. You will oversee the implementation and adherence to the Energy Management System, ensuring that efficiency reviews of Facilities systems operations are conducted regularly. Additionally, you will play a key role in the efficient design review of all new equipment and processes, ensuring they align with best practices and sustainability goals. Key Responsibilities Develop and implement operational/maintenance procedures to ensure best practices and regulatory compliance. Continuously improve Facilities and energy management systems for optimal operational and maintenance efficiency. Act as the SME owner of GMP & Non‑GMP systems as required. Troubleshoot process‑specific equipment and generate data/reports for Annual Product Quality Reviews and regulatory submissions. Lead or participate in cross‑functional teams and support change control and commissioning/qualification activities. Maintain and improve the Energy Management System, ensuring compliance with energy policies, objectives, and relevant regulations. Essential Knowledge & Experience Third‑level qualification in Engineering or Science, or extensive proven experience in relevant fields, with experience in Pharmaceutical, Industrial, or Semiconductor processes. Strong knowledge of GMP, system validation, HVAC & Clean Systems (e.g., Purified Water, Pure Steam, WFI), and control systems; experience in Energy Management Systems is a plus. Familiarity with Health and Safety, Fire Systems, and Environmental Control Systems; excellent interpersonal, communication, and supervisory skills. Strong organizational, planning, problem‑solving abilities, with a proactive approach, good documentation practices, and a flexible work attitude. Education Third level qualification in an Engineering or Science discipline, or extensive related proven experience in the required areas. 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
A leading pharmaceutical company is seeking a Quality Engineer in Tralee, Ireland. This role involves ensuring compliance with GMP and supporting operations in an Aseptic fill finish facility. The ideal candidate will have experience in pharmaceutical processes, strong documentation practices, and excellent communication skills. This is a permanent full-time position requiring 100% on-site presence. Join us to contribute towards patient-focused innovative health solutions. #J-18808-Ljbffr
Join to apply for the EHS Specialist role at Astellas Pharma Description The purpose of the EHS Specialist position is to provide technical support on all Health & Safety and Environmental management systems at the Dublin site. The EHS Specialist shall develop and maintain health, safety and environmental programmes in collaboration with key stakeholders to ensure compliance with all applicable regulations, guidelines and best practices. The scope of activity on site includes 2 manufacturing plants producing Active Pharmaceutical Ingredients (API) of 4 distinct chemical entities, 4 laboratories, support utilities and warehouse. Key Responsibilities Lead or support existing Safety Programmes to include but not limited to Chemical Management (Reach, CLP), Ergonomics, Machine Safety, Risk Assessment, Occupational Health, Occupational Hygiene Monitoring, Legionella etc. Compile and maintain the Health and Safety Legislative Register and Environmental Register. Support maintenance of the safety management system to ISO45001 and environmental management system to ISO14001 to ensure that the policies and procedures are consistent with best practice standards and regulatory requirements and that they also reflect continuous improvement initiatives. Provide support for any external audits and carry out inspections and audits of the site on a regular basis. Promote Health & Safety via competitions, poster campaigns, notice boards and EHS weeks. Support the Health and Safety Awareness Group meeting to ensure employee concerns are addressed and implement suggested improvements as appropriate. Support the operational excellence program on site and digitization of site systems to ensure EHS principles are promoted and central to every role/task on site. Participate in Project Teams to ensure all process/plant/equipment installations are assessed from a health and safety and an environmental perspective. Support accident investigation and participate in root cause investigations of health and safety and environmental incidents/near misses on site to identify corrective and preventative actions. Support the EHS Lab and Environmental Lab to ensure testing is carried out in compliance with the laboratory systems and procedures and provide operational support in testing of samples as required. Ensure waste generated on site is managed in compliance with all relevant IE licence, Irish and EU legislative requirements. Maintain all records and information from a regulatory perspective for hazardous and non-hazardous waste on site. Preferred Knowledge/ Skills & Experience Site-based environmental, health and safety experience working in a manufacturing pharmaceutical environment. Strong knowledge of current Environmental, Health and Safety Legislation/Regulation and current best practice. Proven track record of maintaining environmental, health and safety compliance in a pharmaceutical company. Ability to clearly communicate the environmental, health and safety requirements of activities. Education Educated to degree level in Science, Engineering or equivalent EHS discipline. Postgraduate qualification in Health and Safety if Primary Degree is not in Health and Safety. Environmental Compliance Postgraduate Qualification is an advantage. Additional Information This is a permanent position. Position is based on-site in Dublin. This position is onsite with some flexibility to work from home 1 day a week depending on workload. 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
