Validation Analyst

Job Description

Company Name:                                              PPD Development, L.P.

Position Title:                                                   Validation Analyst

Location:                                                           8551 Research Way, Suite 90, Middleton, WI 53562

Summary of Duties: Validate and Qualify diverse and complex analytical instruments in GMP-regulated environment. Conduct validation or qualification tests of new or existing processes, equipment, or software in accordance with internal protocols or external standards throughout the software development life cycle. Develop validation master plans, process flow diagrams, test cases, validation summary reports and standard operating procedures. Prepare detailed reports or design statements, based on results of validation and qualification tests or reviews of procedures and protocols. Review and approve all change controls associated with validated systems per SOP. Review PQ and change control documentation with leadership per SOP. Ensure test scripts challenge the functional requirements and adequately demonstrate that the application meets the expectations of the business customer. Create, update, and manage sufficient data within the testing environment to accurately test software functionality. Work with leadership to address any PQ related issues arising from client or internal audits. Participate in the identification of user requirements and system design and assists in the preparation and review of system documentation such as requirements and design specifications for software systems and/or instrumentation. Manage assignments to meet deadlines and produce high quality deliverables. Remain familiar with relevant contractual obligations, sponsor expectations, applicable regulations, and SOPs. Participate as a validation representative at project team meetings and complete assigned action items. Provide direction for future releases to software systems; review and approve/reject change requests. Communicate proactively with all project team members and provide regular feedback to management concerning timeline/budget or resource constraints. Remote work available; two days in office and three days remote.

Qualifications: Bachelor’s degree in Information Technology, Science, Chemistry, Environmental Science, Materials Engineering, Integrated Science and Business or related field and two (2) years of experience as Validation Analyst, Validation Engineer, Technical Writer, or related role. Must have eighteen (18) months of 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. One (1) year of experience with: 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). Six (6) months of experience with: Managing computer software validation projects and working with ancillary team members and departments; and Ability to understand the Client and FDA auditing process. Attend Regulatory and Client audits to address any Data integrity concerns.

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