Wondering what’s within Beckman Coulter Diagnostics? Take a closer look. 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 Senior Validation and Verification Engineer for Beckman Coulter Diagnostics is responsible for leading and managing process validation activities in the Co. Clare facility. This position is an 18‑month contract, part of the Validation Department located in the Beckman Coulter facility just outside Tulla in Lismeehan, O’Callaghans Mills, Co. Clare and will be on‑site.
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
Bachelor’s 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 Master’s 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
Join our winning team today. Together, we’ll 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. For more information, visit www.danaher.com.
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