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Validation Analyst
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Company Name: PPD Development, L.P.
Position Title: Validation Analyst
Location: 8551 Research Way, Suite 90, Middleton, WI 53562
Qualifications: Bachelor’s degree in Information Technology, Mechanical Engineering, Materials Science and Engineering, Life Science, Chemistry, or related field and two (2) years of experience as Validation Analyst, Process Engineer, Technical Writer, or related role.. Must have experience with: Software and hardware validation of analytical lab instruments; and Technical writing of documents including Validation Master Plans, Disaster Recovery Plan, Risk assessments, Installation/Operational/Performance Qualification scripts/Validation summary Reports, Incident reports, and Quality Event/Investigation reports; Data analysis using Excel sheets, JMP tool; Trouble shooting of issues associated with Imager Systems, Automated Pipetting system, Fragment Analyzers, PCRs, Spectrometers, X-Ray diffractometers, Materials Testing System, and Thermogravimetric systems; Root cause analysis for software issues including software defects, causes of test failures, and explanation of errors being produced; and Clinical trials operational processes and terminology and the software development life cycle (SDLC); Ability to understand the Client and FDA auditing process. Attend Regulatory and Client audits to address any Data integrity concerns; and managing computer software validation projects and working with ancillary team members and departments.
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