Wondering whats within Beckman Coulter Diagnostics? Take a closer look. At first glance, youll see that for more than 80 years weve been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. Were building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and youll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful. Beckman Coulter Diagnostics is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, were working at the pace of change to improve patient lives with diagnostic tools that address the worlds biggest health challenges. The Senior Validation and Verification Engineerfor Beckman Coulter Diagnostics is responsible for leading and managing process validation activities in the Co. Clare facility. This position is an18-month contract, is part of the Validation Department located in the Beckman Coulter facility just outside Tulla in Lismeehan, OCallaghans Mills, Co. Clare and will be on-site. At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time. You will be a part of the Validation team and report to the Manager Validation and Verification responsible for process Validation activities. You will have responsibility for supporting multiple values streams on site, managing and executing defined validation strategies for the implementation of new products, processes and equipment. If you thrive in a fast paced, multi-functional team role and want to work to build a world-class Quality organizationread on. In this role, you will have the opportunity to: Develop and maintain site master validation plan, procedures, work instructions and templates in line with corporate and regulatory requirements for validation of processes, equipment, equipment software, test methods and utilities Lead, integrate & project manage validation tasks and develop strategies on all validation projects with multifunctional project teams ensuring project objectives are clear and understood, and can be completed as effectively as possible, on-time and compliant to company and regulatory quality and validation standards Provide guidance and support to all departments to ensure they understand and comply with the requirements of cGMP as applied to the validation program set down by company procedures, work instructions and guidelines. Prepare, review and execute site validation protocols (equipment, utilities, processes, cleaning, test methods and software) and final reports ensuring compliance to all relevant corporate and regulatory quality and validation procedures/work instructions and standards Review/Approve change controls and assess impact of changes that affect validated systems and define validation requirements Represent validation at both internal and external audits. The essential requirements of the job include: Bachelors degree in chemistry, biochemistry, engineering or other relevant technical field with a minimum 5+ years experience in a highly regulated (FDA desirable) healthcare or related environment. or Masters degree with a minimum of 3+ years experience or Doctoral degree with 0-2 years experience. Managing change effectively to better serve customers in a busy environment, with demonstrated ability to multi-task and deliver to agreed timelines. Good knowledge of ISO13485, FDA & GMP standards. Understanding and knowledge of the latest regulatory requirements for validation in compliance with EU/U.S. regulations and guidance documents. Strong interpersonal and communication skills with the ability to influence. It would be a plus if you also possess previous experience in: Analytical data analysis. e.g. Minitab Benefits: Pension Fund Medical Aid / Health Care Performance Bonus
Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Beckman Coulter Diagnostics, one of 15+ operating companies, our work saves livesand were all united by a shared commitment to innovate for tangible impact. Youll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danahers system of continuous improvement, you help turn ideas into impact innovating at the speed of life. As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratorys role in improving patient health for more than 90 years. Our diagnostic solutions are used in routine and complex clinical testing, and are used in hospitals, reference and research laboratories, and physician offices around the world. Every hour around the world, more than one million tests are run on Beckman Coulter Diagnostics systems, impacting 1.2 billion patients and more than three million clinicians per year. From uncovering the next clinical breakthrough, to rapid and reliable sample analysis, to more rigorous decision makingwe are enabling clinicians to deliver the best possible car to their patients with improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence. The Staff Manufacturing/Projects Engineer is responsible for the delivery of strategic equipment projects to Beckman European sites: Clare and Krefeld. In this role, you will work with Operations, Engineering and External Equipment Vendors to deliver equipment projects, starting with the development of the User Requirements specifications all the way through equipment validation. You will be responsible for driving continuous improvement initiatives and fostering a culture of technical excellence and problem-solving within the team. This is a permanent role. This position will report to the Manager, Manufacturing Process Engineer, and is part of the Global Engineering team and will be an on-site role at our Clare, Ireland site. In this role, you will be responsible for: Manage Large Scale Equipment Engineering Projects: Works with Operations, and Engineering teams on new equipment designs and is the link engineer to external 3rd party equipment builders to manage the full equipment life cycle. Drive Process Improvement: Lead initiatives to enhance efficiency, reduce waste, and improve product quality using Lean and Six Sigma methodologies. Support Production Operations: Provide hands-on engineering support to resolve manufacturing issues, minimize downtime, and ensure smooth operations. Implement Advanced Technologies: Evaluate and deploy new equipment and automation solutions to boost manufacturing capability and scalability. Ensure Quality & Compliance: Partner with Quality teams to maintain process controls, conduct NC/CAPA, and ensure regulatory compliance. Problem Solving: Utilize process PSP / DIVE to troubleshoot new products / process / equipment while working closely with cross functional team and/or external vendors. Communication: Provide regular effective and clear updates on Equipment and process projects, issues. The essential requirements of the job include: Education: Bachelors degree in: Manufacturing, Industrial, Mechanical, Electrical Engineering, or a related technical field. Experience: 9+ years in manufacturing engineering within a GMP environment. Experience of relevant quality systems (e.g., ISO 13485). Process Improvement: Proven success driving Lean Manufacturing and Six Sigma initiatives; Green or Black Belt certification preferred. Technical Knowledge: Strong understanding of manufacturing processes such as assembly, machining, fabrication, automation, and inspection. Leadership & Problem Solving: Excellent team building, coaching, and analytical skills with a data-driven approach to decision-making. Communication Skills: Strong verbal and written communication abilities, capable of conveying complex technical concepts to varied audiences. Travel, Motor Vehicle Record & Physical/Environment Requirements: Ability to travel 20% It would be a plus if you also possess previous experience in: cGMP MedTech experience Experience with CAD software and statistical analysis tools (e.g., Minitab, JMP). Experience in the life sciences or healthcare industry. Experience with industrial automation (e.g., PLCs, SCADA). Knowledge of AI integration with automation. Experience in a regulated industry Proficiency in project management Beckman Coulter Diagnostics, a Danaher operating company, offers a broad of comprehensive, competitive benefit programs that add value to our lives. Whether its a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at . Skills: Projects Lean Manufacturing Manufacturing Process Engineering Process Improvement Benefits: Pension Fund Medical Aid / Health Care Performance Bonus
Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Beckman Coulter Diagnostics, one of 15+ operating companies, our work saves livesand were all united by a shared commitment to innovate for tangible impact. Youll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danahers system of continuous improvement, you help turn ideas into impact innovating at the speed of life. As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratorys role in improving patient health for more than 90 years. Our diagnostic solutions are used in routine and complex clinical testing, and are used in hospitals, reference and research laboratories, and physician offices around the world. Every hour around the world, more than one million tests are run on Beckman Coulter Diagnostics systems, impacting 1.2 billion patients and more than three million clinicians per year. From uncovering the next clinical breakthrough, to rapid and reliable sample analysis, to more rigorous decision makingwe are enabling clinicians to deliver the best possible car to their patients with improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence. The Staff Manufacturing/Projects Engineer is responsible for the delivery of strategic equipment projects to Beckman European sites: Clare and Krefeld. In this role, you will work with Operations, Engineering and External Equipment Vendors to deliver equipment projects, starting with the development of the User Requirements specifications all the way through equipment validation. You will be responsible for driving continuous improvement initiatives and fostering a culture of technical excellence and problem-solving within the team. This is a permanent role. This position will report to the Manager, Manufacturing Process Engineer, and is part of the Global Engineering team and will be an on-site role at our Clare, Ireland site. In this role, you will be responsible for: Manage Large Scale Equipment Engineering Projects: Works with Operations, and Engineering teams on new equipment designs and is the link engineer to external 3rd party equipment builders to manage the full equipment life cycle. Drive Process Improvement: Lead initiatives to enhance efficiency, reduce waste, and improve product quality using Lean and Six Sigma methodologies. Support Production Operations: Provide hands-on engineering support to resolve manufacturing issues, minimize downtime, and ensure smooth operations. Implement Advanced Technologies: Evaluate and deploy new equipment and automation solutions to boost manufacturing capability and scalability. Ensure Quality & Compliance: Partner with Quality teams to maintain process controls, conduct NC/CAPA, and ensure regulatory compliance. Problem Solving: Utilize process PSP / DIVE to troubleshoot new products / process / equipment while working closely with cross functional team and/or external vendors. Communication: Provide regular effective and clear updates on Equipment and process projects, issues. The essential requirements of the job include: Education: Bachelors degree in: Manufacturing, Industrial, Mechanical, Electrical Engineering, or a related technical field. Experience: 9+ years in manufacturing engineering within a GMP environment. Experience of relevant quality systems (e.g., ISO 13485). Process Improvement: Proven success driving Lean Manufacturing and Six Sigma initiatives; Green or Black Belt certification preferred. Technical Knowledge: Strong understanding of manufacturing processes such as assembly, machining, fabrication, automation, and inspection. Leadership & Problem Solving: Excellent team building, coaching, and analytical skills with a data-driven approach to decision-making. Communication Skills: Strong verbal and written communication abilities, capable of conveying complex technical concepts to varied audiences. Travel, Motor Vehicle Record & Physical/Environment Requirements: Ability to travel 20% It would be a plus if you also possess previous experience in: cGMP MedTech experience Experience with CAD software and statistical analysis tools (e.g., Minitab, JMP). Experience in the life sciences or healthcare industry. Experience with industrial automation (e.g., PLCs, SCADA). Knowledge of AI integration with automation. Experience in a regulated industry Proficiency in project management Beckman Coulter Diagnostics, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether its a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at . Skills: Projects Lean Manufacturing Manufacturing Process Engineering Process Improvement Benefits: Pension Fund Medical Aid / Health Care Performance Bonus
Wondering whats within Beckman Coulter Diagnostics? Take a closer look. At first glance, youll see that for more than 80 years weve been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. Were building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and youll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful. Beckman Coulter Diagnostics is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, were working at the pace of change to improve patient lives with diagnostic tools that address the worlds biggest health challenges. The Analyst II, Technical Project Managementfor Beckman Coulter Diagnostics is responsible for managing all aspects of diverse projects which require technical knowledge and expertise. This is a specific purpose contract. This position is part of the AU Technical Operations department located in Lismeehan, O'Callaghan's Mills, Co. Clare and will be an onsite position. At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time. You will be a part of the Technical Operations team and report to the Senior Manager, Technical Operations. If you thrive in a multifunctional role and want to work to build a world-class Technical Operations organizationread on. In this role, you will have the opportunity to: Deliver/transfer supply chain projects in line with agreed targets and objectives in support of NPI including coordination and/or facilitation of cross functional technical teams to achieve project goals. Laboratory testing in line with technical operations targets and objectives, including qualification of new raw material/ suppliers for clinical chemistry use and failure investigation into problem products, for root cause determination and corrective action recommendations. Documentation of test results and Report generation for SCM files. Technical support to other BC Ireland Inc departments in their internal problem resolution / product maintenance support where relevant. Support of other technical Operations teams as required. The essential requirements of the job include: Degree or Diploma in Chemistry, Biochemistry or equivalent and/or experience in Clinical Chemistry or Immunology Reagent and a mimimum of 2 years relevant work experience Familiar with handling of chemicals, bio-hazardous materials, enzymes and laboratory equipment and analysers. Skills in handling computer software for calculation of data and record keeping. Quality assurance, GMP / FDA / ISO regulations. It would be a plus if you also possess previous experience in: Preparation of reagents. Failure investigation techniques. Project Management Benefits: Pension Fund Medical Aid / Health Care Performance Bonus
