A leading pharmaceutical company in Tralee is seeking a Lyophilisation Lead Engineer to provide technical support for lyophilisation operations and ensure compliance with GMP standards. The ideal candidate has experience in the freeze-drying process within pharma/biotech and strong analytical skills. This permanent full-time position requires on-site presence and involves training staff, technical problem solving, and contributing to improvement projects. Candidates should possess a relevant degree and strong communication skills. #J-18808-Ljbffr
A leading pharmaceutical company in Ireland is seeking a Manufacturing Engineer to support production operations. Your role will include providing technical support, ensuring operational quality, and leading continuous improvement initiatives. Ideal candidates will have a third-level qualification in engineering, significant experience with Lean Manufacturing techniques, and strong problem-solving skills. This is a permanent on-site position at the AICL Kerry Plant. #J-18808-Ljbffr
Manufacturing Engineer About Astellas At Astellas, experience is coupled energised with a relentless challenger spirit. 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 are unusual in our ability to combine the experience, expertise and resources of an established company with the agility, flexibility and tenacity of a start‑up. Relentless curiosity and a hunger for discovery flows throughout our entire organisation. We harness the latest technology and insights from big data with our research expertise to create powerful solutions that could transform the way doctors and nurses treat and care for their patients. We are accelerating product development, driving operational efficiencies and gaining a better understanding of the needs of patients and their healthcare providers. We partner and collaborate with academic research institutes and biotechnology companies who share our passion for bringing breakthrough discoveries to patients. The Opportunity As a Manufacturing Engineer, you will support production operations by providing technical support, troubleshooting, quality assurance input, and continuous improvement leadership. Key Responsibilities Technical Support Provide daily technical support to operating lines. Ensure equipment, material standards, procedures, and specifications are available and effective. Support development of procedures for equipment operation and troubleshooting. Drive technical problem‑solving practices. Operations Performance Support Continuous Improvement through Kaizen, Lean/Six Sigma and problem‑solving. Provide technical support for performance improvement initiatives. Diagnose performance issues and support personnel training. Downtime & Line Reliability Develop systems to minimise technical downtime. Monitor equipment performance to maximise reliability. Quality Systems Ensure effective product, equipment and material standards. Develop and maintain SOPs. Liaise with QA and support closure of TrackWise actions. Support audit preparation. Projects Support performance improvement projects. Generate and approve change controls and protocols. Support capital and non‑capital projects. Product Investigations Provide technical support for investigations. Generate and approve associated reports. Preferred Knowledge & Experience Significant Experience with Lean Manufacturing techniques and implementation. Understanding of Aseptic Production Processing (advantage). Strong problem‑solving skills and initiative. Six Sigma Green or Black Belt & project experience is an advantage. Training in cGMP, Safety, LMS, GDP, Veeva Vault, TrackWise, and HMI systems. Education Third level qualification in Engineering or Technical Discipline or equivalent. Additional Information This position is based in AICL Kerry Plant and will require on‑site work. This is a permanent position. 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 Manufacturing Engineer based in Tralee, Ireland. This full-time position focuses on the installation, maintenance, and troubleshooting of biologics manufacturing equipment, ensuring compliance with FDA and EMA standards. You will collaborate with teams to optimize equipment performance, develop procedures, and lead problem-solving efforts in a fast-paced environment. A minimum of a bachelor's degree in engineering and experience in a GMP setting are required. The role involves approximately 20% travel and is fully on-site. #J-18808-Ljbffr
Description Manufacturing 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 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
Legal Counsel, Product Development & Manufacturing and Pharmacovigilance (Senior Director) 3 days ago – Be among the first 25 applicants Get AI‑powered advice on this job and more exclusive features. About Astellas At Astellas we are a progressive health partner, delivering value and outcomes where needed. We pursue innovative science, focusing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under‑served disease areas and in life‑threatening or life‑limiting diseases and conditions. We work directly with patients, doctors and health‑care professionals on the front line to ensure patient and clinical needs guide our development activities at every stage. 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 buzz‑word – 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 work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real‑world evidence to inform the best decisions for patients and their care‑givers, to ensure the medicines we develop continue to provide meaningful outcomes. Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care. The Opportunity As Legal Counsel – Product Development & Manufacturing and Pharmacovigilance, you will provide senior‑level legal support across Astellas’ global Product Development & Manufacturing (PDM) organization and serve as the primary legal partner for our global Product Development & Manufacturing Functional Unit. Hybrid Working At Astellas we recognise the importance of balancing your work and home life, so we offer a hybrid working solution allowing time to connect with colleagues in person at the office alongside flexibility to work from home, optimising the most productive work environment for you to succeed and deliver. Responsibilities Serve as the strategic legal advisor to PDM across a wide range of commercial manufacturing and supply‑related activities, supporting operations including three manufacturing sites in Ireland. Partner closely with senior PDM leaders, providing proactive legal counsel and helping shape strategic decision‑making. Monitor and interpret legal developments within the pharmaceutical industry, especially manufacturing and supply chain, and advise stakeholders accordingly. Draft, negotiate, and execute a broad range of complex commercial agreements, including contract manufacturing agreements, testing service agreements, engineering agreements, construction service agreements, purchase agreements, commercial supply agreements, quality agreements, and services agreements for supply‑chain vendors. In addition to PDM‑related support, serve as main operational and strategic support to the global Pharmacovigilance team, providing legal support as needed. Essential Knowledge & Experience Qualified lawyer with significant life‑science and/or manufacturing experience. Proven track record and substantial experience handling complex and general commercial matters within the pharmaceutical industry; ideally significant experience supporting a range of manufacturing‑related activities. Strong knowledge and understanding of key business, legal and compliance issues within the pharmaceutical and life‑science industry. Proven ability to influence senior stakeholders and operate effectively in cross‑functional, cross‑border teams. Education Qualified as a Solicitor in England and Wales or Ireland. Preferred Skills & Knowledge Experience working in multi‑functional, cross‑cultural and cross‑country teams, including participation in major cross‑border transactions and projects and managing lawyers and teams in multiple jurisdictions. Additional Information Type of role: Permanent. Location: UK or Ireland. This role follows a hybrid working model, blending home‑based work with a minimum of 1 day per quarter in the office (to be confirmed based on primary location and business need). Flexibility may be required in line with business needs. Seniority level: Director. Employment type: Full‑time. Job function: Legal. Industries: Pharmaceutical Manufacturing. 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 is seeking a Legal Counsel for Product Development and Manufacturing in Ireland. This senior director role requires substantial experience in pharmaceutical law and complex commercial matters, offering a hybrid working model. Responsibilities include advising on legal matters across manufacturing sites, drafting commercial agreements, and supporting compliance efforts. Ideal candidates will have a strong legal background in life sciences and experience influencing senior stakeholders. Join a company committed to innovative health solutions and patient-centric practices. #J-18808-Ljbffr
Lyophilisation Lead 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, allowing 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 provides technical support to the Operations Department by conducting effective investigations, root cause analysis, and implementing corrective actions to ensure efficient lyophilisation operations and adherence to manufacturing schedules. It ensures full compliance with internal and external regulatory, legislative, and statutory requirements, while delivering strategic, value‑adding operational input to support the plant’s technical lyophilisation activities, projects, and initiatives. Acting as the lyophilisation process expert, the role supports the Operations Lead, follows assigned direction, and actively embeds the site’s Operational Excellence Programme across all operations. Responsibilities also include training and developing staff, preparing and maintaining production SOPs and related documentation, completing required LMS training, and promoting strong teamwork and a culture of safety awareness. The role ensures compliance with cGMP, ISO 14001, EMAS, Health & Safety, and Environmental legislation, supports cross‑functional compliance efforts, operates equipment as required to support lyophilisation operations, and undertakes additional duties as directed by the Operations Lead. Responsibilities Provide technical support to lyophilisation operations, engineering, and control systems to ensure efficient, compliant operations and achievement of production and project schedules. Ensure GMP compliance and data integrity of computerised systems within remit, maintaining high system performance in line with site standards and regulatory expectations (FDA, EMA, ICH). Lead and support incident, deviation, and CAPA activities through effective investigation, root cause analysis, and timely implementation of corrective actions. Drive proactive problem solving, process optimisation, and continuous improvement initiatives using Lean Six Sigma, delivering measurable performance, cost, energy, and waste reduction benefits. Manage and contribute to projects, technology transfer, and commissioning activities, providing process engineering expertise and leading or supporting cross‑functional teams. Apply strong analytical, prioritisation, and project execution skills, with experience in PAT, automation, SCADA/HMI, and cycle modelling, while remaining adaptable to changing operational needs. Preferred Knowledge & Experience Experience in freeze‑drying/lyophilisation process development or operations in pharma/biotech. (e.g., Lyomax). Experience in a cGMP start‑up environment is preferred along with advanced technical experience including expert knowledge of aseptic vial lyophilisation process, including CIP, SIP & FIT. Experienced with process control systems, process instrumentation, equipment qualification, and process validation. Possesses excellent organisational, interpersonal, verbal communication and written communication skills. Ability to work effectively using own initiative or as a member of a team as required. Education Bachelor’s or Master’s degree in Chemical Engineering, Pharmaceutical Sciences, Bioprocess Engineering, Biotechnology, or related field, or significant relevant experience. Additional Information This is a permanent full‑time position. Position is based in Tralee – Ireland. 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. #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 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
