Senior Scientist, Validation (Tech Services) Job

Company Name:
Senior Scientist, Validation (Tech
Troubleshooting Tips Job ID: 14521 Location: Phoenix, AZ Offsite Territory: Full/Part Time: Full-Time Regular/Temporary: Regular Category: Project Management Department: Project Management - 3672 Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family. EDUCATION/EXPERIENCE REQUIREMENTS - Requires a Bachelor's degree in Science or Engineering from an accredited college or university with a minimum of 6 years related experience, with at least 2 years validation experience in a pharmaceutical or related industry. - An equivalent combination of education, experience and training may substitute.
SUMMARY The Validation Scientist, Senior develops all qualification and technical services approaches (risk/science based) and provides the scientific rationale documented in protocols and summary reports (including conducting research into industry standards/FDA guidelines), prepares project schedules, heads up project teams, executes validation studies, and performs and interpolates data analysis. ESSENTIAL FUNCTIONS - Designs the qualification approach and provide the scientific rationale and acceptance criteria, generate validation protocols and assist other department members in conducting industry and regulatory research. - Operate instrumentation, executes protocols, and perform validation activities, including collection of samples, resolution of technical issues. In coordination with Production and Validation management, schedule equipment times, prepare test equipment and assure that testing is completed according to approved validation protocols. - Perform complex data analysis (including statistical probability) and prepare written reports/summaries from validation studies. Write/approve validation protocols and assist other department members in conducting research. - Prepare project schedules and update department management on timelines. - Coordinate with applicable departments to ensure project activities are completed as scheduled. - Calibrate or verify calibration of critical processes instrumentation and equipment and prepare documentation of the calibrations related to validation requirements in protocols. - Cross check and verify validation data prepared by others during the regular peer review process. - Serve as a Validation representative for various project teams - Participate and defend validation approaches in regulatory audits. - Process change controls and perform validation non-conformance investigations associated with qualification activities. - Perform daily job functions with minimal guidance and supervision - Conduct training for internal customers on protocols associated with newly validated equipment, systems, processes and specifications when transferring them to responsible operating group. - Write, review and revise department applicable SOPs. - Generate change controls and perform validation non-conformance investigations associated with qualification activities. - Interact and collaborate with departments (on and offsite) as well as vendors, consultants and other external service providers. - Primary responsibilities will specialize in, and/or the following: computerized systems, equipment/facilities/utilities and technical services (PV/CV related). - Perform other duties as assigned. Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. LI-MG1 J2W:PR MYK62683JR

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