You will be in responsible for developing and reviewing equipment/process validation projects with a quality focus and risk-based approach. You will interact on a daily basis and develop strong relationships with Operations and other key internal/external stakeholders. Expert with wide-ranging experience in developing, establishing and maintain quality validation methodologies, systems, and practices which meet regulatory requirements. Serves as a representative to improve awareness, visibility, communication on quality initiatives to support departmental, site and divisional quality goals and priorities such as support cost reduction projects, review validation strategy, protocols and reports with a risk-based approach, manage project schedules with strict adherence to critical milestones, proactively investigates, identifies, and implements best-in-class Quality practices, lead/support in building quality related infrastructure, & instruments including preparation of URS, System Risk Assessment, and subsequent validation, review the Change Control system to determine the impact of proposed changes to the qualification status of equipment and processes, performing root cause analysis and corrective actions for process and equipment-related quality issues, supports internal and external regulatory audits. Who you are: 3 years validation experienceMinimum B.S. degree in scientific fieldFull understanding of product, equipment and process validationDemonstrated capability of applying risk management concepts and toolsHands-on experience in troubleshooting and the application of quality system standardsStrong written and verbal communication skills (internal/external)Strong teamwork and collaboration skillsExperience with GMPs, GCPs, GLPs, GAMP and Part 11 compliance as they relate to qualification of systems in support of validation of processesExperienced with Quality & GxP IT compliance requirements