At Clario, a part of Thermo Fisher Scientific, our Medical Imaging team delivers advanced technology and imaging solutions that support clinical trials across the globe. As a Senior Software Quality Engineer (Verification and Validation), you will play a key role in validating study software, managing test activities, reviewing Computer System Validation (CSV) documentation, and ensuring high-quality, compliant software deliverables. This role is ideal for an experienced software testing professional who thrives in a regulated environment, enjoys leading validation activities, and is motivated by improving quality, efficiency, and patient-focused clinical research outcomes.
Lead validation activities for study software in accordance with Standard Operating Procedures (SOPs), work instructions, Good Clinical Practice, and applicable regulatory expectations.
Review and approve Computer System Validation packages, including test documentation, evidence, defects, and supporting materials.
Review manuals, specifications, and project documentation for testability, clarity, completeness, consistency, risk, and quality gaps.
Partner with developers, study implementation managers, and internal stakeholders to understand project requirements, software changes, risk areas, and mitigation plans.
Define test objectives, design test cases, establish expected results, maintain traceability, and support integration, functional, regression, and performance testing.
Execute test cases, create reliable test evidence, use appropriate test data, and compare expected and actual results to identify deviations.
Document, classify, prioritize, investigate, and retest defects using applicable bug tracking processes and tools.
Set up, maintain, and update configured test environments, including backend systems and testing utilities.
Create and review test documentation required for audits, inspections, internal reviews, external reviews, and regulatory agency requests.
Manage overall test effort across assigned projects, including planning, timelines, resourcing, quality, risks, escalations, and offshore team coordination.
Estimate testing effort, prerequisites, resources, and timelines for upcoming validation activities and project deliverables.
Maintain positive, negative, and boundary test data across applicable modalities and testing scenarios.
Use test management systems, document management systems, bug tracking systems, screenshot tools, and test automation suites to support efficient validation delivery.
Provide accurate status updates on testing progress, open items, defects, risks, and project commitments to internal and external stakeholders.
Support test strategy development, user acceptance testing, customer calls, internal and external audits, and root cause analysis or corrective and preventive action activities.
Identify opportunities to improve testing processes, tools, efficiency, effectiveness, and overall quality.
Mentor and train team members, share testing knowledge, support cross-training, and contribute to departmental goals and continuous improvement.
Bachelor of Technology degree or equivalent qualification in Information Technology, Computer Science, Engineering, or a related field.
5–10 years of software testing, software quality engineering, validation, or verification and validation experience.
Advanced understanding of the software development lifecycle, software testing principles, and regulated validation practices.
Experience managing testing activities across multiple projects, including planning, task assignment, timeline management, risk escalation, and quality oversight.
Strong experience designing, executing, reviewing, and documenting functional, integration, regression, performance, and validation test cases.
Experience with bug tracking systems, test management systems, document management systems, screenshot tools, and test automation suites.
Knowledge of Computer System Validation, Good Clinical Practice, audit readiness, and regulated clinical research or healthcare technology environments.
Advanced knowledge of Agile methodologies and test automation preferred.
ISTQB Advanced Level Test Analyst certification preferred.
Ability to work independently with limited supervision while collaborating effectively with onsite, offshore, cross-functional, and technical teams.
Strong analytical, problem-solving, prioritization, and decision-making skills with excellent attention to detail.
Excellent verbal and written communication skills in English, with the ability to present status, risks, findings, and recommendations clearly.
Ability to work under pressure, manage multiple priorities, meet deadlines, and maintain accountability for high-quality results.
Proactive, self-motivated approach to learning, mentoring, process improvement, and continuous professional development.
At Clario, a part of Thermo Fisher Scientific, our purpose is to transform lives by unlocking better evidence. It’s a cause that unites and inspires us. It’s why we come to work—and how we empower our people to make a positive impact every day. Whether you're advancing clinical science, building innovative technology, or supporting our global teams, your work helps bring life-changing therapies to patients faster.
