LIMS Validation Test Lead (Benchling)
Cognizant
Job Summary We are seeking a LIMS Validation Test Lead to own the testing and validation of cloud-based LIMS in regulated life sciences environments. The ideal candidate has hands-on GxP SaaS validation experience, ideally with Benchling , though we also welcome experience with similar platforms such as Benchling alternatives like Signals, BIOVIA, or LabVantage. You will define a risk-based testing strategy, evaluate vendor validation packages, and lead onshore and offshore test teams. You will also serve as the primary client-facing contact for testing, ensuring every deliverable is audit-ready and aligned with GAMP 5, 21 CFR Part 11, EU Annex 11, and ALCOA++ principles. Please note, this role is not able to offer visa transfer or sponsorship now or in the future About the Role As the LIMS Validation Test Lead, you will be the testing and validation authority on our Benchling implementations and enhancements. You will work closely with clients, project teams, and offshore testers to make sure each release is thoroughly tested, fully traceable, and ready for audit. This is a hands-on leadership role. You will set the direction for how testing is done, then stay close to the work: reviewing test design, guiding execution, and making sure the evidence stands up to regulatory scrutiny. In This Role, You Will Testing strategy & planning Develop and document risk-based testing strategies for Benchling Validated Cloud implementations and enhancements. Prepare detailed test plans, scope definitions, and entry/exit criteria to ensure business and regulatory requirements are covered. Analyze and validate vendor-supplied validation/testing packages for Benchling; identify gaps and recommend remediation. Design and implement end-to-end STLC processes (requirement analysis, test design, execution, reporting, and closure). Champion risk-based testing methodologies; perform thorough risk assessments to prioritize validation activities and manage residual risk. Test design, execution & defect management Create UAT, functional, integration, and regression test scripts and test data tailored to Benchling workflows and integrations. Lead test execution, capture test evidence, and maintain traceability between requirements, test cases, and results. Oversee defect lifecycle using JIRA: logging, triage, prioritization, root cause analysis, retest and closure. Maintain and report test metrics and status to stakeholders; escalate risks and impediments proactively. Domain & Benchling expertise Serve as the go-to expert for testing of the user requirements for Benchling application workflows, configuration, integrations, and data model. Ensure test artifacts and evidence align with GAMP 5 guidance, GxP expectations, 21CFR Part11, EU Annex 11, and ALCOA++ data integrity principles. Tooling, automation & GenAI Hands-on expertise with JIRA and the Xray plugin #J-18808-Ljbffr Cognizant
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