VALIDATION SPECIALIST MO IN ITALIA

Act as a strategic partner, providing value-added solutions, developing and implementing hands-on measures in order to realize the required process improvements and ultimately improve margins; Drive changes and efficiencies by recommending new ways to operate, contributing actively to their actual implementation and providing feedbacks; Build realistic and comprehensive action plans to reduce cost, increase quality and improve service level; Participate at meetings with Automation department in order to define the technical requirement specifications for new equipments considering R&D, QA and Operations requests; Define, execute and validate the production process of new product in collaboration with R&D; Define, write and update production manual (MOP) and guarantee the quality for the entire process; Transfer production process; Execute process changes related to: methods, parameters and material changes; Execute Operational Qualification (OQ) and Performance Qualification (PQ); Execute equipment and production validation using statistical tools such us Gage R&R, Capability analysis, DOE, Regression, Hypothesis tests and others. Promote process improvements using Lean Six Sigma Approach.Multinational Company leader in medical devicesGreat Growth OpportunityGood English level (B1 Level) Management of the validation documents necessary for the process control and improvement and deep knowledge of validation strategy (IQ - OQ - PQ); Knowledge and experience with statistical tools: DOE study, Gage R&R, Capability analysis (Cp, Cpk, Pp, Ppk), sampling size definition preferably by means Minitab sw. Degree in Engineering Green Belt Certification will be a plusAt least 2-3 years of experience holding position in process engineering dept.Multinational Company leader in medical devicesGreath Growth Opportunity