About Beckman Coulter Diagnostics
We are a leading global medical technology company dedicated to advancing and optimizing the laboratory to move science and healthcare forward.
Our team is passionate about making a meaningful difference in patient lives, and we are committed to building a culture that celebrates backgrounds, experiences, and perspectives of all our associates.
We are invested in our employees, providing the opportunity to build a 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, working together to improve patient lives with diagnostic tools that address the world's biggest health challenges.
Senior Validation and Verification Engineer
This 9-month contract position is part of the Validation Department located in the Beckman Coulter facility in Lismeehan, OCallaghans Mills, Co. Clare.
The Senior Validation and Verification Engineer will lead and manage process validation activities in the Co. Clare facility, reporting to the Manager Validation and Verification.
You will have responsibility for supporting multiple value streams on site, managing and executing defined validation strategies for the implementation of new products, processes, and equipment.
In this role, you will:
* Develop and maintain site master validation plan, procedures, work instructions, and templates in line with corporate and regulatory requirements.
* Lead, integrate & project manage validation tasks and develop strategies on all validation projects with multifunctional project teams.
* Provide guidance and support to all departments to ensure they understand and comply with the requirements of cGMP as applied to the validation program.
* Prepare, review, and execute site validation protocols and final reports ensuring compliance to all relevant corporate and regulatory quality and validation procedures/work instructions and standards.
* Represent validation at both internal and external audits.
Essential Requirements
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.
* 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.
Benefits
The Senior Validation and Verification Engineer will receive:
* Pension Fund
* Performance Bonus
* Medical Aid / Health Care