Test Engineer

«out Wipro Wipro Limited (NYSE: WIT, BSE: 507685, NSE: WIPRO) is a leading technology services and consulting company focused on building innovative solutions that address clients’ most complex digital transformation needs. We leverage our holistic portfolio of capabilities in consulting, design, engineering, operations, and emerging technologies to help clients realize their boldest ambitions and build future-ready, sustainable businesses. A company recognized globally for its comprehensive portfolio of services, strong commitment to sustainability and good corporate citizenship, we have over 250,000 dedicated employees serving clients across 66 countries. We deliver on the promise of helping our customers, colleagues, and communities thrive in an ever-changing world. A PROUD HISTORY OF OVER 75 YEARS FY22 REVENUE 10.4 BN USD WE’RE PRESENT IN 66 COUNTRIES OVER 1,400 ACTIVE GLOBAL CLIENTS Role GXP-Validation Test Manager Key Skills Location Chicago, Illinois Roles & Qualifications Job title: GXP-Validation Test Manager Purpose of the position Directly manage assigned projects to satisfy specific project/client needs - Plan, schedule, execute, and lead CSV Compliance assignments wrt validation and 21 CFR Part 11 GXP compliance Performing Compliance evaluation of client procedures and systems wrt equipment, facilities and computerized systems used in GLP, GMP and GCP environments. Lead, coordinate, and interface with cross-functional project teams in for deliverables within the agreed timeline. Support development of validation best practices based on current industry practices Required to be on the site in Chicago, IL or nearshore supporting Chicago time zone Key responsibilities Implement and own the testing strategy/planning (functional, integration, performance). Implement and execute the test plan with the project team. Own, maintain and optimize the automated testing infrastructure. Lead the continuous integration and continuous delivery efforts. Lead the automation activities and deliver our product releases with the highest quality to customers. Be a process lead, including responsibility for mentoring your team, ensuring best practices, & inspire a quality mindset. Work with the Q&RA team to improve completeness and robustness of the V&V portion of the DHF. Oversee manual testing to understand the features and architecture of our products. Weight in with other leaders to collectively make decisions that are best for the business and ensure the successful delivery of the product. Interact with product owner, development teams and stakeholders to develop a strong understanding of the product and testing objectives. Participate in design reviews as well as ensure design requirements and specifications are testable. Coach and mentor colleagues about verification and validation. Propose streamlining and best practices to further accelerate validation delivery and reduce costs Ensure compliance with SLC processes; validation must be delivered in standardized tools and functional as SLC evidence during audit support Work experience & skills Familiarity with GxP systems (POMSnet, Maximo, OSI PI, SampleManager, Empower, Trackwise, ComplianceWire, Antares, Warehouse Serialization Solution, Discoverant) Experience with Kneat (App Change Management), qTest (ALM), & Tosca (automated testing) Knowledge of FDA and European compliance regulations and GAMP guidelines applicable to CSV Familiar with off-the-shelf, configurable, and custom-developed applications validation. Experienced with various technologies and automated systems used in the pharmaceutical industry - Business System (ERP etc), Quality System (Track wise, LIMS etc), PLC or SCADA, Process Control, Laboratory Instrumentation, Data archive/historian, etc Experienced with tools - electronic document management systems (e.g., Documentum, DocuSign, Valgenisis, Kneat, SharePoint etc.); application development and lifecycle management (e.g., HP ALM, JIRA, DevOps etc.); and IT service management systems (e.g., SAP Solution Manager, etc.) Solid experience in test automation and continuous integration. Solid experience in functional & performance testing and driving system specs into test plans. Strong verbal and written communication skills and presentation skills in English. Excellent understanding of verification methodology and software development life cycle. Wipro is an Equal Employment Opportunity employer and makes all employment and employment-related decisions without regard to a person's race, sex, national origin, ancestry, disability, sexual orientation, or any other status protected by applicable law.
LI-SJ3 Medical Design - Verification Standards