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(Denken Solutions, Inc. has openings in Irvine, CA) Senior QA Validation Engineer: Perform final review and issue final approval of validation and re-validation protocols and reports, (IQ / OQ / PQ), for the validation of new and existing processes, medical devices, equipment, clean rooms (ISO8, ISO7 and ISO5), and systems. Oversee and guide the writing of and execution of protocol documents, deviation resolution, traceability matrices, and summary reports. Coordinate and guide technical support to maintenance technicians on required modification to comply with FDA regulations. Oversee and coordinate the preparation, maintenance, and review of validation and compliance documentation, such as engineering change notices, schematics, or protocols. Coordinate with regulatory agencies regarding compliance documentation and validation results. Perform final review and issue final approval of equipment/systems and provide recommendations. Responsible for identifying existing and potential operational problems and inefficiencies and recommending resolutions. Utilize Laboratory Information Management Systems (LIMS), TrackWise, Corrective Action and Preventive Action (CAPA), and Delta V. Will work in various unanticipated locations throughout the U.S. Requires Masters in Pharmaceutical Sciences, Public Health, or related and 2 years experience. $94,349.00 per year. Send resume and refer to job title to Denken Solutions, Inc. 9170 Irvine Center Drive, Suite #200, Irvine, CA 92618 or immigration@denkensolutions.com.