Validation Engineer

We are looking for a contract to hire Validation Engineer to join our medical device manufacturing client in Southeastern Wisconsin! This position is responsible for writing, implementing, analyzing results and summarizing process validation activities in the areas of equipment installation, change management, and continuous lifecycle improvement. This individual will work through a validation backlog following the Quality System elements for process Validation including CAPAs and deviations. This position will work closely with members of the Quality Assurance, Manufacturing, and Engineering teams to develop process validation studies and projects to enhance the manufacturing processes to compliantly achieve organizational goals.Duties Of RoleProvide technical input to validation activitiesRepresent process validation during equipment installationsSupport process validation Quality SystemsIdentify opportunities for personal and professional development, continuous improvements, and help deploy best practicesParticipate in regulatory agency inspections for Process ValidationServe as one of the main points of contact in communication to customers whose equipment and processes are being validatedResponsible for updating site Project Management and aiding in schedule and cost forecasting of validation activitiesMust Haves:3 or more years relevant experience in quality/validationExperience authoring and completing validation studies.Understanding of cGMP requirements for validation documentation.Demonstrated ability to collaborate with multiple functions to implement validation activities and incorporate validation results into routine operational practicesExperience authoring and building process validation studies for commercial GMP manufacturing processesExperience troubleshooting/problem-solving and risk assessment/mitigationWorking knowledge of the science and technology for the major unit operations associated with manufacturing operation is considered a plus.Must be able to read, write and speak EnglishHourly Rate of $40-50 while on contract