Job Description
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. Join a team where you can be heard, be supported, and always be yourself. Were building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. 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. Beckman Coulter Diagnostics is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, were working at the pace of change to improve patient lives with diagnostic tools that address the worlds biggest health challenges. The Manager Validation & Verificationfor 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, OCallaghans 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 afast paced, multi-functional teamroleand want to work to build a world-classQualityorganizationread 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: 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. 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 Skills: Validation Process Validation Method Validation Verification Quality Management System Benefits: Pension Fund Medical Aid / Health Care Performance Bonus