Software Validation Engineer

Parexel is hiring a Software Validation Engineer to join our global team. This role will be accountable to validate and maintain the software quality within PI Informatics. This role will provide key inputs for validation during the software development lifecycle (SDLC).

Key Accountabilities:Testing-- Accepts responsibility for creation of test cases using own in-depth technical analysis of both functional and non-functional specifications (such as reliability, efficiency, usability, maintainability and portability). Creates traceability records, from test cases back to requirements. Produces test scripts, materials and regression test packs to test new and amended software or services. Specifies requirements for environment, data, resources and tools. Records and analyses actions and results, and maintains a defect register. Reviews test results and modifies tests if necessary. Provides reports on progress, anomalies, risks and issues associated with the overall project. Reports on system quality and collects metrics on test cases. Provides specialist advice to support others.Quality assurance -- Conducts formal audits or reviews to ensure compliance with organizational standards for activities, processes, data, products or services. For projects, development or support activities; plans, organizes and conducts audits and determines whether appropriate quality control has been applied. Collates, collects and examines records, analyses the evidence and drafts all or part of formal compliance reports. Determines the risks associated with findings and non-compliance and proposes corrective actions. Provides advice and guidance in the use of organizational standards. Consultancy -- Takes responsibility for understanding client requirements, collecting data, delivering analysis and problem resolution. Identifies, evaluates and recommends options, implementing if required. Collaborates with, and facilitates stakeholder groups, as part of formal or informal consultancy agreements. Seeks to fully address client needs, enhancing the capabilities and effectiveness of client personnel, by ensuring that proposed solutions are properly understood and appropriately exploited.Business process testing -- Designs and manages tests of new/updated processes. Specifies test environment for whole life-cycle testing (e.g. using model office concept). Manages selection/creation of relevant scenarios for testing and ensures that tests reflect realistic operational business conditions. Ensure tests and results are documented, reported to stakeholders and are available for specification of user instructions. Highlights issues and risks identified during testing to business stakeholders. Provides specialist guidance and advice to less experienced colleagues and users to ensure that test are conducted in an appropriate manner.QualificationsSkills:Excellent interpersonal skills, verbal and written communication skillsA flexible attitude with respect to work assignments and new learningAbility to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail. Shows Initiative and self-confidence is adaptable and is able to cope with changing and evolving priorities. Must have the ability to work methodically in a fast-paced, time-sensitive environment Manages provision of consultancy services. In own areas of expertise, provides advice and guidance to consultants and/or the customer or other stakeholders through involvement in the delivery of consultancy services Knowledge and Experience: 3+ years’ experience in a software testing environment (preferably medical devices)Experience in a FDA regulated software environmentExperience in creating and designing test cases, test scripts, summary reports and test plans Black Box testing techniques like Boundary Value analysis and Equivalence PartitioningAutomation experience a plus21 CFR Part 11 experience a plusEEO DisclaimerParexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.