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 Diagnosticsis 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. As aValidation Engineer - 12- month FTCfor Beckman Coulter Diagnostics, you will be responsible for supporting 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 have 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 Validation team and report to the Validation Manager in the Quality and Regulatory Affairs function. You will have responsibility for supporting multiple values streams on site and executing to defined validation strategies for the implementation of new products, processed and equipment. If you thrive in a fast paced, multi-functional team environment and want to work to build a world-class Quality organizationread on. In this role, you will have the opportunity to: Represent validation function on multi-functional project teams, lead validation tasks ensuring objectives are clear and understood, consistent and compliant with corporate and regulatory requirements, and can be completed as effectively as possible. Provide guidance and support to 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 and approve changes to assess impact of the change on validated systems and define validation requirements if needed. Plan and contribute to validation project schedules and drive the achievement of this schedule through continuous monitoring of schedule progress, effective risk and issue management and prioritization of validation activities in line with the project schedules and plant priorities. The essential requirements of the job include: Bachelors degree in field with a minimum of 2 years' experience in a relevant field OR relevant Masters degree OR relevant Doctoral degree Good working knowledge of GMP & Quality & Safety standards Understanding and knowledge of the latest regulatory requirements for validation in compliance with EU/U.S. regulations and guidance documents Excellent written and communication skills It would be a plus if you also possess previous experience in: Managing change effectively in order to better serve customers in a busy environment, with demonstrated ability to multi-task and deliver to agreed timelines. Providing technical expertise during investigations, gap analysis, risk assessment and change control process Using lean methodologies (such as DBS) to achieve targets At Beckman Coulter Diagnostics we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible to work part-time at the Company location identified above and part-time remotely from your home. Additional information about this work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Beckman Coulter Diagnostics can provide. Skills: Validation GMP Quality Management Benefits: Pension Fund Medical Aid / Health Care Performance Bonus
