VALIDATION ANALYST

Company Name: PPD Development, L.P.
Position Title: Validation Analyst
Location: 8551 Research Way, Suite 90, Middleton, WI 53562

Summary of Duties: Provide basic business/system support of software systems and/or laboratory instrumentation. Work with staff of various departments and the client to initiate and complete performance qualification (PQ) validation. Facilitate the validation process and implementation of system upgrades, including guiding, testing, and supporting the introduction and ongoing support of software systems. Participate as a validation representative at project team meetings. Provide direction for future releases to software systems. Review and approve or reject change requests. Communicate proactively with all project team members and provide regular feedback to management concerning timeline/budget or resource constraints. Provide validation support for new releases and modifications to applications throughout the software development life cycle. Prepare validation plans, test cases and validation summary reports, and execute test cases. 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. Execute test scripts accurately to produce evidence that the computer system consistently performs its intended functions accurately and reliably, proving the software functions correctly. 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. Manage assignments to meet deadlines and produce high quality deliverables. Remain familiar with relevant contractual obligations, sponsor expectations, applicable regulations, and SOPs. Participate in the identification of user requirements and system design and assist in the preparation and review of system documentation such as requirements and design specifications for software systems and/or instrumentation. Work from home available; must be able to report to local Middleton, WI office.

QualificatQualifications: Bachelor’s degree in Computer Science, Computer Engineering, Pharmaceutical Science, Environmental Science, Biotechnology, or related role, and two (2) years of experience as a Validation Engineer, Validation Specialist, or related role. Two (2) years of experience with: System validation and qualification processes; System/Software development life cycle; Applying Good Manufacturing Practices towards validation/qualification projects; SOP authorship, revision, or review within a document management system; Change and Asset Management within a computerized asset management system; Addressing system defects/incidents within a computerized defect management system; Independently leading/managing validation and/or qualification efforts; Performing initial and/or Periodic Reviews of systems for regulatory compliance ; and Responding to internal QA audit findings.ions: Bachelor’s degree in Computer Science, Computer Engineering, Pharmaceutical Science, Environmental Science, Biotechnology, or related role, and two (2) years of experience as a Validation Engineer, Validation Specialist, or related role. Two (2) years of experience with: System validation and qualification processes; System/Software development life cycle; Applying Good Manufacturing Practices towards validation/qualification projects; SOP authorship, revision, or review within a document management system; Change and Asset Management within a computerized asset management system; Addressing system defects/incidents within a computerized defect management system; Independently leading/managing validation and/or qualification efforts; Performing initial and/or Periodic Reviews of systems for regulatory compliance ; and Responding to internal QA audit findings.