Our client offers a unique, world-class opportunity for interested candidates. They have been consistently ranked a "Top Employer" in Science Magazine's rankings for pharmaceutical and biotechnology companies. Our client is fully committed to bringing their award-winning approach to their subsidiary in Ireland, and is looking for outstanding people who are excited by a start-up environment, recognize the opportunities that this offers and wants to be challenged.Summary: Implements policies and procedures to validate/qualify equipment, systems, and processes in accordance with regulatory requirements and company manufacturing standards.Essential Duties and Responsibilities include, but are not limited to, the following: Reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria Analyzes the results of testing and determines the acceptability of results against pre-determined criteria. Aids in investigations and troubleshooting as part of a multi-functional team to determine solutions or recommendations for changes and/or improvements. Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions. Reviews, edits and approves change control and SOPs Coordinates with other departments or outside contractors/vendors to complete validation tasks. Reviews, edits and approves reports, such as, Automation performance evaluation reports, and other reports or documentation submitted to the department Trains/advises less experienced Specialists and Technicians. Assesses quality system documentation for completeness and accuracy, and dispositions documentation within the client SOPs. Manages projects and prepares status reports.Experience And Required Skills :* BS/BA in Engineering, Chemistry, or Life Sciences with years of related experience within the field preferred; may substitute relevant experience for education.This is an opportunity to join our Clients selected team that is already leading the way in the Pharmaceutical/Biotech industry.