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At first glance, you’ll see that for more than 80 years we’ve 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. We’re building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and you’ll 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, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges. 

The Manager Validation and Verification for Beckman Coulter Diagnostics is responsible for process validation activities in the Co. Clare facility.

This position is part of the Validation Department located in the Beckman Coulter facility in Lismeehan, O’Callaghans Mills, Co. Clare and will be on-site, with some flexibility to work from home. At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time.

You will be a part of the Operations Quality team and report to the Senior Manager Quality Assurance responsible for the Operations Quality functions. You will have responsibility for supporting multiple values streams on site, managing and executing defined validation strategies for the implementation of new products, processed and equipment. If you thrive in a fast paced, multi-functional team role and want to work to build a world-class Quality organization—read on.

In this role, you will have the opportunity to:

Lead a Team of Validation Engineers engaged in site validation activities including equipment, utilities, processes, cleaning, test methods and equipment software qualifications.

Plan and develop the validation elements of site project schedules with different business center managers and ensure project objectives and resources are agreed, including prioritization of validation activities in line with the project schedules and plant compliance priorities.

Lead, integrate & project manage validation tasks and develop strategies on validation projects with multi functional 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.

Direct, support and supervise the activities of reporting validation and verification engineers and adapt departmental plans and priorities to meet service and/or operational challenges and agreed KPIs.

Represent Co. Clare Validation Team in Corporate Process Validation Team responsible for the development and implementation of corporate process validation procedures and best practice guidance and templates.

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.

The essential requirements of the job include:

Bachelor’s degree in chemistry, biochemistry, engineering or other relevant technical field with a minimum of 9 years’ experience in a highly regulated (FDA desirable) healthcare or related environment, or Master’s degree with a minimum of 7 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:

Using lean methodologies, such as DBS, to achieve targets

At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.