A leading biopharmaceutical company is seeking a Senior Temperature Mapping Validation Engineer in Dublin. The role involves leading temperature mapping activities compliant with GMP regulations, executing protocols for critical equipment, and collaborating with various departments. Required qualifications include a degree in Engineering or Science and at least 5 years of validation experience in GMP settings. Strong communication, organizational, and regulatory knowledge are essential. The role offers a valuable opportunity to contribute to quality assurance and validation processes. #J-18808-Ljbffr
Business Support Analyst – Alexion Pharmaceuticals, Inc. Location: ADMF College Park Reports To: Aidan Cronolly – Associate Director / Engineering Systems Job posted: 05-Dec-2025 | Closing: 04-Jan-2026 Responsibilities Manage all Managed Service Providers & Outsourced Vendors for Maintenance & Calibration Activities with the Engineering Department. Oversee the Vendor Managed Inventory (VMI) program for QC & BDS Operations. Create and generate all Engineering‑related Purchase Orders. Maintain contractor records through relevant systems. Maintain Managed Service Provider contracts & Purchase Orders. Track all Vendor related costs through the budget cycle. Manage the VMI program on behalf of BDS & QC Labs. Attend weekly/bi‑weekly VMI meetings. Develop and oversee engineering department performance metrics. Serve as subject‑matter expert for all Engineering Purchase Orders. Maintain & report all required weekly/monthly KPIs. Provide support to all Engineering groups as needed. Develop annual Vendor Service Level Agreements. Coordinate with Quality to ensure required Quality Agreements with vendors. Liaise with Planner / End‑User to ensure scheduled activities completed, SLA and CMMS compliance. Assist with monthly accrual query resolution. Set up new vendors in line with AVL / ASL requirements. Act as the Quality System point of contact for all Engineering SNOC’s & ECMS Quality System SME. Required Qualifications Degree/Diploma or Technical certification in a related field. Minimum 2–3 years of experience in Maintenance, Facilities or General Engineering. 2–4 years experience in a cGMP commercial manufacturing environment. Knowledge of regulatory and GMP requirements for maintenance activities, instrumentation and calibration. Preferred Qualifications Prior experience with Computerised Maintenance Management Systems. Strong interpersonal, communication and problem‑solving skills. Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form. #J-18808-Ljbffr
Senior Temperature Mapping Validation Engineer Join to apply for the Senior Temperature Mapping Validation Engineer role at Alexion Pharmaceuticals, Inc. The Senior Temperature Mapping Validation Engineer will be accountable for planning, executing, analyzing, and documenting temperature mapping activities across critical and Controlled Temperature Units (CTUs) at the Alexion Manufacturing Dublin facility (ADMF). This includes the qualification of fridges, freezers, incubators, cold rooms, autoclaves, and steam-in-place (SIP) cycles. This role will ensure Temperature Mapping qualification and requalification activities completed comply with regulatory requirements, validation lifecycle management, internal procedures, and industry best practices. Key Responsibilities Lead the planning, execution, and documentation of temperature mapping and requalification studies for GMP-critical equipment. Ensure compliance with validation lifecycle principles and change control processes. Lead a team of technicians to ensure Validation activities are completed in a timely manner to meet schedule. Develop and approve temperature mapping protocols, plans and reports in accordance with site procedures and regulatory requirements e.g. cGMP, EU, and FDA requirements. Collaborate with cross-functional teams including Quality, Engineering, Facilities, Supply Chain etc. to ensure timely completion of validation activities. Support investigations and deviations related to temperature excursions or environmental monitoring. Analyse data, process trends, validation outcomes, and recommend appropriate corrective actions. Participate in audits and inspections, providing subject matter expertise on temperature mapping qualification. You Will Need To Have Bachelor’s degree in Engineering, Science, or related discipline. Minimum 5 years of experience in temperature mapping or validation within a GMP-regulated environment. Strong knowledge of temperature mapping equipment, loggers, calibration, and data analysis tools. Ability to keep work pace and meet deadlines. Good organization and planning skills. Strong knowledge of regulatory requirements (EU GMP Annex 1, Annex 15, FDA, ICH Q9/Q10). Excellent communication, organizational, and project management skills. Preferred Skills Technical Degree in Engineering/Life Sciences or greater preferred. 24-Nov-2025 23-Dec-2025 Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form. Dublin, County Dublin, Ireland #J-18808-Ljbffr
A leading biopharmaceutical company based in Dublin is seeking a Business Support Analyst to manage vendor relationships, maintain Engineering Purchase Orders, and ensure compliance with regulatory standards. The ideal candidate will have a Degree/Diploma in a related field and 2-3 years of experience in Maintenance or General Engineering. This role offers an opportunity to contribute to operational excellence in a cGMP environment. Join us to make a meaningful impact in a collaborative atmosphere. #J-18808-Ljbffr
A leading biopharmaceutical company in Dublin is seeking a Senior Manager, Lead Process Engineer to drive continuous improvement in drug substance manufacturing processes. This role includes managing process engineering projects, collaborating with stakeholders, and ensuring compliance with safety and regulations. Candidates should have over 8 years of experience in the BioPharma industry, strong technical skills, and excellent leadership abilities. The position is full-time and offers an exciting opportunity to influence manufacturing excellence. #J-18808-Ljbffr
Are you ready to lead the charge in optimizing drug substance manufacturing processes? As a Senior Manager, Lead Process Engineer , you’ll be at the forefront of driving continuous improvement and ensuring high standards for safety, compliance, sustainability, and process excellence. You will support Alexion’s strategic vision for multi‑product manufacturing at College Park, collaborating with NPI Project Teams to align processes with plant capabilities, meet timelines, and achieve production targets. Accountabilities Identify and implement process optimization/process safety projects throughout the facility. Manage and coordinate a portfolio of process engineering projects. Serve as Process SME on all manufacturing processes within the Bulk Drug Substance facility at College Park. Review design/specification of equipment and systems to ensure compliance with regulations and compatibility with the existing BDS facility. Evaluate new Process Equipment and NPI processes for long‑term operability of the plant. Assess New Product Introduction Design Changes to prevent impacts on existing manufacturing processes. Collaborate with other discipline leads on process issues and lead a team of engineers in identifying solutions. Own process‑related aspects of projects, providing technical support to the design team. Build relationships with key stakeholders within the facility to ensure completion of critical projects and initiatives related to BDS manufacturing. Support Global teams in Basis of Design and Facility Fit studies for future site capability. Assist in regulatory inspections for both new and existing process equipment. Develop a long‑term strategy for optimization projects based on business forecasting. Oversee planning and execution of process optimization testing on live equipment safely and compliantly. Champion safe working practices and safety initiatives within the functional area. Essential Skills/Experience Minimum 8 years of experience in a relevant technical or managerial role within the BioPharma industry, focusing on Drug Substance Process Optimization/Design. Ability to manage a wide portfolio of projects and prioritize as required by the business. Excellent technical abilities with a base in engineering. Ability to keep work pace and meet deadlines. Good organization and planning skills. Strong leadership and communication skills. Problem solver with a focus on achievement of overall project goals. Ability to work independently with minimum direct supervision. Experience in issue description, root cause identification, technical/quality impact assessment & corrective action justification. Must be goal‑oriented and able to prioritize and manage tasks. Desirable Skills/Experience Technical Degree or higher in Engineering. Experience in managing technical teams. Lean accreditation. Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form. Seniority level: Mid‑Senior level Employment type: Full‑time Job function: Management and Manufacturing Date posted: 28-Nov‑2025 Closing date: 11-Dec‑2025 #J-18808-Ljbffr
Global Supply Chain Planning Partner Associate Director Join to apply for the Global Supply Chain Planning Partner Associate Director role at Alexion Pharmaceuticals, Inc. Job Summary The Global Supply Chain Planning Partner serves as a strategic interface between Alexion Rare Disease Global Supply Chain and AstraZeneca’s Commercial Marketing Companies and Global Supply Chain teams. This role focuses on ensuring seamless integration and optimization of supply chain activities with a particular emphasis on demand management insights. By fostering collaboration and facilitating information sharing, the successful candidate will enhance the alignment of supply chain processes with marketing strategies, supporting business objectives and improving patient outcomes. Key Responsibilities Develop and input integrated demand forecasting processes that align with both Alexion and AstraZeneca’s strategic objectives, utilizing advanced analytics and market insights. Ensure demand alignment between supply chains and commercial teams, driving effective inventory and supply decisions through accurate forecasting. Serve as the primary liaison between Alexion and AstraZeneca’s Global Supply Chain teams on all aspects of demand management, facilitating effective communication and fostering collaboration to streamline operations. Engage with cross‑functional teams, including Marketing, Sales, Operations, and Supply Chain, to align strategies and supply capabilities with market demands. Organize and lead regular cross‑team meetings to share insights, discuss challenges, and develop coordinated action plans. Analyze demand and supply data to generate actionable insights that inform strategic decision‑making and drive operational improvements. Provide comprehensive reports and dashboards to senior leadership, highlighting key trends, opportunities, and potential supply chain bottlenecks. Identify opportunities to enhance supply chain efficiency and effectiveness, implementing best practices and innovative methodologies. Collaborate on initiatives aimed at optimizing inventory levels, reducing costs, and maintaining high service levels. Establish and track key performance indicators (KPIs) related to demand management, supply chain performance, and alignment with marketing objectives. Regularly assess and report on the alignment of supply chain activities with overall business goals, recommending process improvements as necessary. Education Bachelor’s degree in Supply Chain Management, Business Administration, Data Science, or a related discipline. Advanced degree (e.g., MBA, MS) is preferred. Required Qualifications 8–12 years of experience in supply chain planning, demand management, or a related field, preferably within the pharmaceutical or biotechnology industry. Demonstrated experience in managing cross‑functional and cross‑organizational projects, ideally in a global context. Experience with supply chain planning and analytics tools (e.g., OMP, SAP, Oracle, Kinaxis, Anaplan). Technical Skills Strong analytical and quantitative skills, with expertise in supply chain modeling and data analysis. Proficiency in statistical forecasting and demand planning techniques. Soft Skills Exceptional communication and interpersonal skills, with the capability to influence and build alignment among diverse teams. Strong organizational capabilities and the ability to manage multiple priorities and workstreams effectively. Strategic, solution‑oriented mindset with a strong emphasis on problem‑solving. Key Competencies Collaborative Leadership: Ability to build robust cross‑organizational relationships, fostering trust and collaboration. Analytical Acumen: Expertise in translating complex data into strategic insights and actionable plans. Strategic Alignment: Focused on aligning supply chain and marketing efforts to maximize business impact and support overall objectives. Innovation and Improvement: Advocates for adoption of new processes and technologies, continuously seeking opportunities to enhance supply chain performance. Why Join? As the Global Supply Chain Planning Partner, you will play a pivotal role in integrating and optimizing supply chain and commercial demand management processes between Alexion and AstraZeneca. Your efforts will not only contribute to improving supply chain efficiency but will also ensure that life‑changing therapies reach patients effectively. This position offers the opportunity to drive collaboration and innovation in a dynamic, global organization committed to making a meaningful impact on patient health worldwide. Date Posted 01-Dec-2025 Closing Date 31-Dec-2025 Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form. Referrals increase your chances of interviewing at Alexion Pharmaceuticals, Inc. by 2x Seniority level Mid‑Senior level Employment type Full‑time Job function Management and Manufacturing #J-18808-Ljbffr
A leading biotechnology firm in Dublin seeks a Global Supply Chain Planning Partner Associate Director to strategically bridge supply chain activities with marketing objectives, enhancing patient outcomes. This mid-senior level role involves leading demand forecasting and managing cross-functional collaborations. Candidates should have 8-12 years of relevant experience, strong analytical capabilities, and proficiency with supply chain tools. This full-time position offers the opportunity to significantly influence global supply chains and improve patient health outcomes. #J-18808-Ljbffr
Are you ready to lead the charge in optimizing drug substance manufacturing processes? As a Senior Manager, Lead Process Engineer, you'll be at the forefront of driving continuous improvement and ensuring high standards for safety, compliance, sustainability, and process excellence. You'll play a pivotal role in supporting Alexion's strategic vision for multi-product manufacturing at College Park, collaborating with NPI Project Teams to align processes with plant capabilities, meet timelines, and achieve production targets. Your expertise will guide stakeholders in Manufacturing, Engineering, and Quality to enhance existing processes and optimize plant performance and throughput. Accountabilities: Identify and implement process optimization/process safety projects throughout the facility. Manage and coordinate a portfolio of process engineering projects. Serve as Process SME on all manufacturing processes within the Bulk Drug Substance facility at College Park. Review design/specification of equipment and systems to ensure compliance with regulations and compatibility with the existing BDS facility. Evaluate new Process Equipment and NPI processes for long‑term operability of the plant. Assess New Product Introduction Design Changes to prevent impacts on existing manufacturing processes. Collaborate with other discipline leads on process issues and lead a team of engineers in identifying solutions. Own process‑related aspects of projects, providing technical support to the design team. Build relationships with key stakeholders within the facility to ensure completion of critical projects and initiatives related to BDS manufacturing. Support Global teams in Basis of Design and Facility Fit studies for future site capability. Assist in regulatory inspections for both new and existing process equipment. Develop a long-term strategy for optimization projects based on business forecasting. Oversee planning and execution of process optimization testing on live equipment safely and compliantly. Champion safe working practices and safety initiatives within their functional area. Essential Skills/Experience: Minimum 8 years of experience in a relevant technical or managerial role within the BioPharma industry, focusing on Drug Substance Process Optimization/Design. Ability to manage a wide portfolio of projects and prioritize as required by the business. Excellent technical abilities with a base in engineering. Ability to keep work pace and meet deadlines. Good organization and planning skills. Strong leadership and communication skills. Problem solver with a focus on achievement of overall project goals. Ability to work independently with minimum direct supervision. Experience in issue description, root cause identification, technical/quality impact assessment & corrective action justification. Must be goal‑oriented and able to prioritize and manage tasks. Desirable Skills/Experience Technical Degree or higher in Engineering. Experience in managing technical teams. Lean accreditation. At AstraZeneca, we are driven by a passion for innovation and a commitment to making a difference in the lives of patients with rare diseases. Our unique culture fosters collaboration, creativity, and growth, empowering you to explore new ideas and develop your skills. With a rapidly expanding portfolio, you'll be part of an energizing environment where your contributions have a meaningful impact. Join us in our mission to change lives for the better, supported by exceptional leaders and peers who are dedicated to advancing healthcare. Ready to make an impact? Apply now and be part of our journey! Date Posted 28-Nov-2025 Closing Date 11-Dec-2025 Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form. #J-18808-Ljbffr
A leading biopharmaceutical company in Dublin is seeking a Senior Manager, Lead Process Engineer. You'll optimize drug substance manufacturing processes and lead projects to enhance safety and compliance. The ideal candidate has 8+ years in process optimization within the BioPharma industry, excellent leadership skills, and a strong technical background. Join us to make a meaningful impact in healthcare. #J-18808-Ljbffr
