Job Description
About Us
Beckman Coulter Diagnostics is a leading provider of diagnostic solutions that help healthcare professionals make better decisions to improve patient lives.
We are committed to advancing and optimizing the laboratory to move science and healthcare forward.
Role Summary
The Staff Validation and Verification Engineer will be responsible for leading and managing process validation activities in our Co. Clare facility.
This position will be part of the Validation Department located in the Beckman Coulter facility in Lismeehan, OCallaghans Mills, Co. Clare and will be on-site.
Key Responsibilities
1. Lead and manage workloads for specific teams of validation & verification engineers for validation projects in line with company goals.
2. Plan and develop the validation elements of site project schedules and ensure project objectives and resources are agreed.
3. Lead, integrate & project manage validation tasks and develop strategies on validation projects with multifunctional project teams.
4. Mentor, train and support validation and verification engineers in validation principles.
5. Represent Co. Clare Validation Team in Global Process Validation Team responsible for the development and implementation of corporate process validation procedures and best practice guidance and templates.
6. 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.
Requirements
* 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.
* 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
* Pension Fund Medical Aid / Health Care Performance Bonus