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.
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.
Together, were working at the pace of change to improve patient lives with diagnostic tools that address the worlds biggest health challenges.
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.
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.
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: Bachelors 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 Masters 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.