Live What you will do Let'sdo the world At Amgen, every detail matters - especially when it comes to our people. We're seeking a Senior Associate, Payroll to join our Dublin team, supporting accurate and compliant payroll operations across multiple entities. Working closely with the Payroll Manager, HR Operations, and Finance, this role ensures precision in payroll inputs, data integrity, and vendor coordination - delivering a first-class employee experience. Key Responsibilities: Process high volume weekly and monthly payrolls across several Amgen Ireland entities. Ensure payroll accuracy under compressed timeframes. Reconcile and validate data across several platforms, Workday, Softworks, excel, etc. Support managers with sign-off and compliance to time and attendance policies. Respond promptly to payroll-related queries from employees, HR, and business partners with a customer-focused approach. Prepare and maintain payroll documentation for internal, external, and ad-hoc audits (ERR, IICC, EY, Mercer, Revenue, etc.). Support HR and Finance with reconciliations, payment approvals, and Bank fund release confirmations. Provide holiday cover within the payroll team to ensure uninterrupted service delivery. Maintain process notes and audit trails for all payroll activities, ensuring full compliance and traceability. Participate in system testing, process improvement, and automation initiatives to enhance accuracy and efficiency. Support HR administration by tracking incomplete data and maintaining accurate records across systems. Assist in the preparation of statutory submissions such as ESA and Gender Pay Gap reports. Win What we expect of you Thesuccessful candidate for this role will bring the following education,skillsand experience 3+ years' experience in Republic of Ireland payroll operations within a large or multinational environment. Recognized payroll qualification (IPASS or equivalent). Strong technical understanding of payroll, taxation, and statutory compliance requirements. Experience with Workday, Softworks, and third-party payroll providers (advantageous). Advanced Excel skills (VLOOKUPs, Pivot Tables). High attention to detail, accuracy, and confidentiality with sensitive data. Ability to manage multiple priorities and meet tight deadlines. Collaborative approach with strong communication and stakeholder engagement skills. Continuous improvement mindset with a proactive, solution-oriented approach. Thrive What you can expect of us In addition toa competitive salary structure,Amgen offers agenerousTotal Rewards Planforstaff and eligible employee benefits package, includingretirement andsavingsplan with generous company contributions, group medical,lifeand disability annual bonus learning, development and career advancement opportunities, empowering employees to growand build long-term careers. At Amgen, we are committed to nurturing talent and providing meaningful pathways for professional development. Amgen is an equal opportunities employer 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.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. With a deep and broad pipeline of potential new medicines, we continue to advance science to serve patients. Amgen Dun Laoghaire (ADL) activities include Biopharmaceutical Aseptic Manufacturing, Lyophilisation and Automated Inspection & Packaging. Role Purpose The F&E Technical Services Manager is a key member of the Site Facilities & Engineering and technical team. With primary responsibility for leading the QC Technical Services function, the manager will also manage the Amgen calibration equipment and standards lifecycle. The role ensures the reliable, compliant, and efficient lifecycle management of the applicable equipment at the Amgen Dun Laoghaire site. The position combines day-to-day operations and project responsibilities. The day-to-day operations include hands-on technical leadership, equipment maintenance and people management. The role also involves project work including the introduction of new capabilities in partnership with specialist project engineers and external service providers. Key Duties and Responsibilities: Technical Leadership & People Management Lead, coach, and develop a team of Technical Specialists; set clear objectives, manage performance, and support succession and capability development. Plan, prioritize, and coordinate team workloads to meet operational demands and project timelines. Promote a culture of technical excellence, compliance, safety, and continuous improvement. QC Equipment Lifecycle Management Oversee calibration, requalification, and routine maintenance of QC laboratory equipment utilizing the site CMMS system (Maximo/SAP). Own and govern the qualification lifecycle for new and existing laboratory equipment, including protocol review and approval. Ensure periodic review and ongoing compliance of validated QC equipment and systems Calibration Systems & Standards Lifecyle Management Oversee calibration, requalification, and routine maintenance of Calibration equipment systems and Standards utilizing the site CMMS system (Maximo/SAP). Represent ADL as the calibration representative within the global metrology network. Support alignment with enterprise standards and contribute to cross-site improvement initiatives. Data Integrity, Compliance & Inspection Readiness Ensure robust data integrity controls aligned with regulatory expectations (e.g. electronic records and audit trails). Support deviations, investigations, CAPAs, and change controls related to applicable equipment and systems. Ensure continuous inspection readiness and support regulatory and internal audits. Projects, Upgrades & Cross-Functional Collaboration Partner with specialist project engineers to deliver laboratory equipment upgrades and new capabilities. Provide technical input to capital and improvement projects from design through commissioning and handover. Collaborate closely with QC Operations, Manufacturing, QA, Engineering, Validation, Technology, EHS, and external vendors. Operational Excellence & Vendor Management Manage key service providers and vendors to minimize equipment downtime and maintain high service standards. Track KPIs, analyze trends, and drive continuous improvement initiatives to improve equipment reliability and performance. Basic Qualifications & Experience: Bachelor's degree in Science, Engineering, or a related discipline. Significant experience in a cGMP-regulated QC laboratory environment with expertise in laboratory equipment operation, qualification and maintenance. Prior experience leading or supervising technical professionals. Strong knowledge of regulatory expectations for QC laboratory equipment and computerized systems. Understanding of analytical techniques and instrumentation utilized in biopharmaceutical methods and testing. Experience with calibration processes and principles. Preferred Qualifications & Experience: Master's degree in a relevant scientific or engineering discipline. Experience acting as system owner for QC laboratory equipment or computerized systems. Demonstrated success delivering equipment-related projects in a regulated environment. Experience working with CMMS systems such as Maximo. Strong leadership, communication, and stakeholder influencing skills. 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.
Amgen Dun Laoghaire (ADL) is looking for a Senior Engineer to join our Inspection Engineering team to support the continued expansion of the plant and production capability on site. Amgen Dun Laoghaire (ADL) is a 37,000 square metre aseptic drug product operations facility, specialising in secondary manufacturing activities - Formulation, Vial/Syringe Filling, Lyophilisation and Inspection. This position will be responsible for the performance and introduction of new syringe inspection equipment on site. The Sr. Engineer will take ownership of a system(s) and will be seen as a subject matter expert and contact person for any process or technical related requirements of said equipment. The engineer will report to the Engineering Manager and should be proficient in the use of statistical analysis tools, continuous improvement methodologies, problem solving and applied engineering skills relating to mechanical, electro-mechanical and associated automation systems. Previous experience in installation, servicing and maintenance of Inspection & packaging equipment would be a distinct advantage. The engineer will also have full overall responsibility for the reliability and life cycle of equipment and previous hands-on experience in resolving automation system issues would be a distinct advantage. Key Responsibilities Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations. Ownership of equipment/systems in a GMP regulated manufacturing setting. Monitoring of day-to-day performance of their assigned system. Data trend analysis of all performance aspects of their system and equipment to identify and proactively manage performance trends. Proactively identify opportunities for continuous improvement in equipment & processes as well as preventative maintenance support to technicians for regular activities. Anticipate issues and plan effective preventative solutions in a timely matter and plan works around a busy manufacturing schedule and defined available resources. Lead and support system improvements, development of detailed specifications, engineering documents and standard operating procedures. Ownership of all GMP documentation and their accuracy throughout the lifetime of the equipment (e.g. Risk assessments, Functional Design, User Requirement specifications etc.) Lead technical root cause analysis, incident investigations and troubleshooting issues related to manufacturing equipment/systems and follow up to ensure learnings are actioned. Designing, executing, implementing and directing engineering or process projects which significantly contribute to attaining high system performance. Working in a collaborative manner within the Process Teams structure and contributes to investigations, Non-Conformance and CAPA closure. Development of FAT, SAT, IOQ and other testing documents and ensuring that any activities on the equipment is acceptable to achieve GMP & business goals. Ensuring that a critical spare parts list for their system is identified and appropriate levels of spares are maintained. Maintain a structured plan for future improvements and downtime for equipment. Support new product introductions or new technology introductions by performing engineering assessments, implementation of system changes and supporting engineering runs. Basic Qualifications: Bachelor's degree in engineering (Mechanical, Electrical or Mechatronic preferred) Senior level experience of providing technical solutions in the medical device, pharmaceutical inspection or medical packaging sectors. Demonstrated solid leadership, with the ability to build teams and operate across functional boundaries, both internal and external. Experience in change control, non-conformance, corrective and preventative actions, and validation practices. Demonstrated experience of vendor management and contract negotiations with focus on equipment suppliers, SLA's and continuous supplier performance. Significant experience large project related activities including GMP qualification experience. Preferred Experience Typically, 5+ years' engineering experience in an automated inspection of pharmaceutical, combination products or medical device product environment. Experience supporting highly automated and high-speed equipment lines essential. Automation and vision system experience an advantage Ability to influence the development of business area strategy and engineering/equipment strategy where appropriate Experience of building dashboards and using AI (specifically machine learning) to present real time performance and to create tools which can identify possible future events ahead of occurrence. Independent, self-motivated, organized, able to multi-task in a production environment Team player, prepared to work in and embrace a team-based culture that relies on collaboration, support other areas to meet business requirements. Travel at various times may be required to support execution of projects 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.
Live What you will do Let's do this. Let's change the world. Amgen Dun Laoghaire (ADL) is looking for a Senior Equipment Process Engineer to join our Drug Product Engineering team to support commercial aseptic Drug product filling on site. Amgen Dun Laoghaire (ADL) is a 37,000 square metre aseptic drug product operations facility, specialising in secondary manufacturing activities - Formulation, Vial/Syringe Filling, Lyophilisation and Packaging. This position will be responsible for performance drug product equipment on site. The Senior Equipment Process Engineer will report to the Engineering Lead and should have knowledge and proficiency in the use of statistical analysis tools, continuous improvement methodologies, problem solving and applied engineering skills relating to mechanical, electro-mechanical and associated automation systems. The Senior Equipment Process Engineer will also have full overall responsibility for the reliability and life cycle of equipment. Key Responsibilities Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations. Ownership of equipment/systems in a GMP regulated manufacturing setting that support the Drug Product manufacturing processes. Monitoring of day-to-day performance, including trend analysis of all performance aspects of their system and equipment to identify and proactively manage performance trends. Lead and support system improvements, development of detailed specifications, engineering documents and standard operating procedures. Lead technical root cause analysis, incident investigations and after action reviews when troubleshooting issues related to manufacturing equipment/systems. Lead solving complex problems, project management, equipment lifecycle management and operational excellence initiatives related to their systems / equipment. Develop and manage change control requests per established SOPs and processes. Support new product introductions or new technology introductions by performing engineering assessments, implementation of system changes and supporting engineering runs. Communicating with key stake holders, in a responsive manner to ensure they are kept informed on all engineering activities. Working in a collaborative manner within cross functional work centre team, and contributes to investigations, Non-Conformance and CAPA closure. Responsible for a structured maintenance schedule which will align with the manufacturing schedule to minimise downtime. This includes routine PM's and long term planning for vendor support on site and the procurement of major spare part assemblies in a timely manner to support larger overhauls. Responsible for the development and maintenance of spare parts lists for their system and appropriate levels of spares are maintained. Win What we expect of you The successful candidate for this role will bring the following education, skills and experience. Basic Qualifications: Bachelor's degree in Engineering (Mechanical, Manufacturing, Mechatronics, Electrical or Chemical). Manufacturing experience in a regulated environment. Experience in the use of statistical analysis tool & continuous improvement methodologies. Problem solving and applied engineering skills relating to mechanical, electro-mechanical and associated automation systems. Preferred Qualifications: Manufacturing experience in biopharmaceutical Formulation/Fill/Finish or Active Pharmaceutical Ingredient (API) facilities. Direct experience supporting either Vial or Syringe Filling equipment. Solid leadership, technical writing, and communication/presentation skills. Experience in change control, non-conformance, corrective and preventative actions, and validation practices. Experience in developing strategies for new product introduction and new technology deployment. Ability to translate strategic opportunities and emerging technology solutions into tangible pragmatic executable plans. Ability to influence the development of business area strategy and engineering/equipment strategy where appropriate. Development and presentation of project plans to senior management. Day to day vendor management and contract negotiations with focus on equipment suppliers. Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration. Team player, prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making. Travel at various times may be required to support execution of projects. Thrive What you can expect of us In addition to a competitive salary structure, Amgen offers a generous Total Rewards Plan for staff and eligible dependents. Comprehensive employee benefits package, including retirement and savings plan with generous company contributions, group medical, life and disability insurance. Discretionary annual bonus program. Exceptional learning, development and career advancement opportunities, empowering employees to grow and build long-term careers. At Amgen, we are committed to nurturing talent and providing meaningful pathways for professional development. Amgen is an equal opportunities employer 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.
Live What you will do Let's do this. Let's change the world. Amgen Dun Laoghaire (ADL) is looking for a Senior Equipment Process Engineer to join our Drug Product Engineering team to support commercial aseptic Drug product filling on site. Amgen Dun Laoghaire (ADL) is a 37,000 square metre aseptic drug product operations facility, specialising in secondary manufacturing activities - Formulation, Vial/Syringe Filling, Lyophilisation and Packaging. This position will be responsible for performance drug product equipment on site. The Senior Equipment Process Engineer will report to the Engineering Lead and should have knowledge and proficiency in the use of statistical analysis tools, continuous improvement methodologies, problem solving and applied engineering skills relating to mechanical, electro-mechanical and associated automation systems. The Senior Equipment Process Engineer will also have full overall responsibility for the reliability and life cycle of equipment. Key Responsibilities Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations. Ownership of equipment/systems in a GMP regulated manufacturing setting that support the Drug Product manufacturing processes. Monitoring of day-to-day performance, including trend analysis of all performance aspects of their system and equipment to identify and proactively manage performance trends. Lead and support system improvements, development of detailed specifications, engineering documents and standard operating procedures. Lead technical root cause analysis, incident investigations and after action reviews when troubleshooting issues related to manufacturing equipment/systems. Lead solving complex problems, project management, equipment lifecycle management and operational excellence initiatives related to their systems / equipment. Develop and manage change control requests per established SOPs and processes. Support new product introductions or new technology introductions by performing engineering assessments, implementation of system changes and supporting engineering runs. Communicating with key stake holders, in a responsive manner to ensure they are kept informed on all engineering activities. Working in a collaborative manner within cross functional work centre team, and contributes to investigations, Non-Conformance and CAPA closure. Responsible for a structured maintenance schedule which will align with the manufacturing schedule to minimise downtime. This includes routine PM's and long term planning for vendor support on site and the procurement of major spare part assemblies in a timely manner to support larger overhauls. Responsible for the development and maintenance of spare parts lists for their system and appropriate levels of spares are maintained. Win What we expect of you The successful candidate for this role will bring the following education, skills and experience. Basic Qualifications: Bachelor's degree in Engineering (Mechanical, Manufacturing, Mechatronics, Electrical or Chemical). Manufacturing experience in a regulated environment. Experience in the use of statistical analysis tool & continuous improvement methodologies. Problem solving and applied engineering skills relating to mechanical, electro-mechanical and associated automation systems. Preferred Qualifications: Manufacturing experience in biopharmaceutical Formulation/Fill/Finish or Active Pharmaceutical Ingredient (API) facilities. Direct experience supporting either Vial or Syringe Filling equipment. Solid leadership, technical writing, and communication/presentation skills. Experience in change control, non-conformance, corrective and preventative actions, and validation practices. Experience in developing strategies for new product introduction and new technology deployment. Ability to translate strategic opportunities and emerging technology solutions into tangible pragmatic executable plans. Ability to influence the development of business area strategy and engineering/equipment strategy where appropriate. Development and presentation of project plans to senior management. Day to day vendor management and contract negotiations with focus on equipment suppliers. Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration. Team player, prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making. Travel at various times may be required to support execution of projects. Thrive What you can expect of us In addition to a competitive salary structure, Amgen offers a generous Total Rewards Plan for staff and eligible dependents. Comprehensive employee benefits package, including retirement and savings plan with generous company contributions, group medical, life and disability insurance. Discretionary annual bonus program. Exceptional learning, development and career advancement opportunities, empowering employees to grow and build long-term careers. At Amgen, we are committed to nurturing talent and providing meaningful pathways for professional development. Amgen is an equal opportunities employer. 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.
This role will require the candidate to provide process development support to new product introductions (NPI), technology transfer, lifecycle changes to syringe products, provide subject matter expertise for product formulation, filling and characterisation to support ADL1and ADL1X (SF01, SF02 and SF03) production. The candidate will provide technical support to drug product manufacturing at ADL as well as be part of the global Process Development (PD) organization. The input provided will also include support of process performance and implementation of process improvement strategies and will include the following: Leads new product introductions and lifecycle changes into SF01, SF02 and SF03 from a Process Development perspective and then serves as the Process Development SME for these products following completion of the transfer. Be a key contributor to regulatory filings as part of the NPI process throughout the authoring, editing and submission process but also be responsible for response to regulator questions as and when required. Acts as a drug product manufacturing technical expert to provide solutions when troubleshooting drug substance freezing/thawing, formulation, filling syringes/devices, inspection, and transportation for parenteral products through the NPI or post-NPI phases. Provide process development expertise for commercial drug product processing in specific areas such as sterile processing, process characterization, tech transfer and validation. Support commercial drug product manufacturing operations with technical evaluation of NC/CAPA and technology transfer. Interfaces with manufacturing as well as all support functions to provide robust and coordinated support to manufacturing. Develops and characterizes drug product processes and transfers technology to commercial drug product sites. Identifies and implements operational opportunities for current and new sterile operations. Troubleshoots issues with drug product processing technologies and equipment. Leads and conducts risk assessment for drug product operations and propose / implement appropriate CAPA. Responsibilities may include leading cross-site teams to support the above activities, providing recommendations to management. Provide support to the PD forensic lab and be a link to manufacturing on key investigations as a process expert. Development of validation plans, process performance qualifications (PPQs) for syringe filling. Ensuring all aspects of activity within any given process validation adheres to required policies and procedures, including safety and training. Ensure that the site meets the quality requirements of its customers and applicable regulations (FDA, EU & international standards). Participate and lead in validation cross functional teams at the site to ensure adherence to required policies and procedures. Assist in the development of any existing validation program to ensure continued compliance to the necessary regulations. Input to site validation guidance documents. Collate and report on relevant shipping and filter validation. Pre-approve and post-approve process validation protocols and assessments from a quality system documentation perspective. Contribute to product quality assessments and process flow documents. Liaise with Operations, Engineering and external vendors regarding new or amended equipment which would impact the validated process. Lead or assist in deviation and exception resolution and root cause analysis. Participate as required in project activities and be developing own project management techniques. Basic Qualifications: A third level Bachelor's degree in Science, Engineering or a relevant Quality discipline with 5 years' experience in a similar role OR Master's degree & 3 years of directly related experience OR Associate's degree & 10 years of directly related experience Knowledge of cGMPs and other worldwide regulatory requirements. Problem solving ability and excellent oral and written communications skills. Preferred Qualifications: PhD or Masters in Science or Engineering 5+ years of experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as Sterile Processing, Process Characterization, Tech Transfer (to commercial DP sites) or Validation. Strong skills in applying fundamental engineering and scientific principles to the design, implementation and process validation of protein freeze-thawing, filtration, mixing, filling, and/or lyophilization processes. Knowledge of protein biochemistry regarding chemical and physical stability Project management skills including the ability to manage multiple projects and evaluate project resource requirements. Strong knowledge of Quality systems, Drug Product Manufacturing and Validation. Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion. Excellent Communication skills are essential for this role. Amgen is an equal opportunities employer. 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.
This position is for a Sr Associate Tech Engineering, to join the Process Development Commercial Support team based in Amgen Dun Laoghaire (ADL). The team is responsible for providing process and product support to drug product formulation and fill-finish operations in ADL as drug product process SMEs. Core responsibilities will include: Day-to-day operations support in sterile drug product unit operations such as formulation, vial filling, pre-filled syringe filling, lyophilization and vial capping. Generate product impact assessments associated with process excursions and deviations, with reference to product technical documentation. Acting as a subject matter expert during change controls, assessing the impact of proposed changes on the product and process performance. Supporting new product introductions (NPI), including recipe and protocol development, batch execution support and troubleshooting. Driving continuous improvement initiatives to enhance process capability, reduce variability and improve productivity. Analysing manufacturing data trends to identify opportunities for improvement and prevent potential issues. Reviewing and approving GMP documentation such as SOPs, electronic batch records, and product technical documentation. Risk assessments and mitigation projects relating to filling line performance. The chosen candidate will work in a collaborative manner within the process team structure and contribute as a member of cross functional teams within the local organization and functional team globally. Basic Qualifications: Bachelor's, Masters or PhD degree in Science, Engineering or related discipline with 2+ years experience in a similar role. Direct Experience supporting vial/pre-filled syringe filling operations. Preferred Qualifications Thorough knowledge of GMP biotechnology manufacturing, with a significant understanding and knowledge of cGMPs. Experience with regulatory agency audits is beneficial. Strong problem-solving technical skills related to parenteral drug product manufacturing. 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.
HOW MIGHT YOU DEFY IMAGINATION? If you feel like you're part of something bigger, it's because you are. At Amgen our shared mission-to serve patients-drives all that we do. It is key to becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing and delivering ever-better products that reach millions of patients worldwide. It's time for a career you can be proud of. Join us! HOSPITAL SALES SPECIALIST - GENERAL MEDICINE LIVE What you will do In this vital role you will be responsible for the promotion of our General Medicine product portfolio to ensure optimal uptake and usage. Diagnosing requirements and assuming responsibility for evaluating, developing, and commercialising external opportunities in line with Amgen strategy. Key responsibilities include: Achieve regional sales targets Support identification of opinion leaders and develop engagement plan. Translate national plan to produce a regional plan of action to ensure achievement of account priorities and regional and national brand strategy, involving key internal stakeholders to ensure alignment and prioritisation of activities. Ensure all activities agreed within the account plans are implemented to completion within time, cost, and compliance and quality constraints. Develop metrics for success and tracks progress relative to targets. Maintain effective collaboration within own and cross-functional teams to ensure alignment, progress updates and knowledge share. All role activities are required to meet Amgen standard operating procedures, reporting, compliance, and quality standards, whilst demonstrating the Amgen Values Be part of our team You would be joining The General Medicine Business Unit, a team with a clear ambition and energy to grow Amgen's business within the portfolio. With a full portfolio and a rapidly approaching innovative pipeline, it is an exciting place to be! WIN What we expect of you We are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional, are these qualifications and skills: Degree educated in a relevant field, ideally in a scientific discipline Proven track record of sales, high performance in a hospital sales environment Experience in selling into Cardiology, Care of the Elderly, Gastroenterology, Rheumatology or Dermatology is highly preferred Track record of developing and managing strategic relationships with senior stakeholders Experience of working with cross functional teams and ability to influence customer and brand strategy THRIVE What you can expect of us As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being. Vast opportunities to learn and move up and across our global organization Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits LOCATION Republic of Ireland - Dublin South,South Leinster and Munster APPLY NOW for a career that defies imagination In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us. Amgen is an Equal Opportunity employer and will consider you without regard to your race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation. 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.
Summary: Site lead for Contract Manufacturing Organizations (CMOs). Single point of accountability and interface between Amgen and assigned external partners. Responsibilities: Manufacturing operations: Develop and lead robust business processes, maintain reliable relationships with contract site management; assess industry trends, internal network, and technology advancements as tools to improve contract site performance. Manage budget development, monitoring, and reporting; create and manage contracts - confidentiality disclosure agreement(s), scope of work agreement(s), request for pricing/information, supply agreement(s) etc.; monitor and improve financials with CMO; actively manage and communicate forecasts to the sites and manage capacity planning. Drive operational excellence and champion change. Site performance monitoring: Manage contract site performance using lean tools and PDCA, lead site operating review meetings; drive improvements at contract sites; sustain and improve the overall health of the business, and lead communication/relationship with the contract site as well as internal management. Project Management and Technology transfer: Lead a department-wide project from conception to implementation and close-out. Present to and obtain buy-in for value proposition of such projects to senior management. Provide oversight of all planning and coordination of product transfer activities to the contract site(s); develop, present, and obtain approval of budget, timeline and ensure execution of transfer team activities to achieve seamless product transfer to the contract site(s); ensure risk management initiatives are taking place as per RM plan; lead site issue management and resolution; provide issue escalation to executive management. Qualifications: Minimum requirements (as per standard) Preferred Requirements: Bachelor's in Business Administration, Engineering, or Science-related field 5+ years of experience in DP, or packaging manufacturing environment 5+ years in roles requiring knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles 2+ years of experience working with external parties and/or leading cross-functional teams for clinical and/or commercial products 1+ years of project management experience leading multi-functional and multi-location team 1+ years of experience across ACDM Ability to travel +/- 20% of time (domestic and international) Location: Ireland Competencies: Demonstrated competencies of lower GCF levels. Demonstrated matrix management and influencing skills. Manufacturing and cGMP knowledge / experience. Demonstrated negotiation skills. Operational Excellence proficiency and ability to drive continuous improvement. Financial/budgeting knowledge and business acumen. Proficient project management skills. Problem-solving and critical thinking. Understanding of contractual requirements. Technical writing and multi-level communication skills. Demonstrated ability to lead effectively in collaborative/team environment. Demonstrated ability to take initiative, drive action, and work under minimum supervision. 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.
Primary Responsibilities: The Senior Maintenance Technician will report to a Maintenance Manager and will work as part of one of the site maintenance teams (Process, Utilities, Lyophilisation, Inspection, Packaging) with the primary responsibilities laid out below. As the site expands, development opportunities may exist to transfer internally between teams and to gain experience with the equipment in each area of the plant mentioned above. Equipment Maintenance Execute advanced maintenance activities on process equipment in accordance with standard operating procedures across multiple production and support facilities. Perform troubleshooting and equipment investigation works while assuring minimal impact to plant operations and in compliance with good maintenance practices, SOP's and GMP requirements. Ability to work independently and as part of a team, taking responsibility for completion and handover of work, GMP documentation and ongoing maintenance of personal system qualifications. Demonstrated ability to participate in cross-functional teams to investigate non-conformances, deviations, and troubleshoot issues to establish root causes and corrective actions. Proactively integrate evolving technology and tools deployed as part of predictive maintenance strategies. Projects and Continuous Improvement Support projects and start-up of new process plant and equipment. Support process investigations, trials, machine upgrades and testing in conjunction with the wider engineering team. Assist with the development, execution, and support of the CQV (Commissioning, Qualification, Validation) process. Identify and implement local projects to enhance equipment operation, reliability, and the efficiency of maintenance programs. GMP and Compliance Maintain high levels of aseptic compliance and housekeeping standards in manufacturing areas, workshops and training areas whilst operating as part of a cross functional team to support the plant. Demonstrated ability to self-maintain online and practical training or qualification status in compliance with site operating procedures and key area metrics. Ensure activities are undertaken in a safe, compliant manner in accordance with legislative, site and corporate safety and quality procedures. Adopt compliance driven industry changes to document and record GMP activities. Documentation Ensure that maintenance documentation and records are completed accurately and in accordance with applicable procedures such as ALCOA+ principles. Develop, revise & review relevant technical documents (Maintenance SOP's, Job Plans, P&IDs etc.) in conjunction with the broader Engineering support team. Familiarity with the purpose and use of CMMS systems, Electronic Batch Records, and electronic logs or recording systems. Primary Knowledge and Education: Recognised apprenticeship in an electrical / mechanical craft. Ability to read and understand mechanical drawings, technical manuals, electrical wiring schematics, layout drawings and P&ID's. Preferred Qualifications and Experience: Combined education, training and experience in mechanical / electrical maintenance, experience in a regulated manufacturing environment would be an advantage. Knowledge and experience working in a pharmaceutical or aseptic manufacturing facility. Understanding of pneumatic, mechanical, and hydraulic systems with the ability to effectively perform any associated maintenance or troubleshooting activities. Working knowledge and experience of site utilities and electrical systems. Relevant experience in an automated manufacturing and inspection environment would be an advantage. Experience executing and documenting maintenance work in a computerised maintenance management system. Ability to interpret P&ID's, identify hazards, isolation points and inter-dependencies between services for LOTO purposes. Ability to work with minimum direction, identify issues and effectively communicate the status of equipment or tasks in a timely manner. 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.
