Sr Software Quality Engineer (V&V)

Clario Holdings Inc.; Bengaluru; On-site; INR 1,800,000 - 2,400,000; Full time

Benefits offered by this job

Provident fund and medical insurance

Remote work flexibility

Modern office spaces

Job summary

Clario is seeking a Senior Software Quality Engineer (Verification and Validation) in Bengaluru to lead validation activities for study software in a regulated setting. You will review CSV packages, maintain test artifacts, and coordinate with cross-functional teams to ensure compliant, high-quality software deliverables.

The role requires 5–10 years of software testing and a strong grasp of GCP-aligned validation practices, agile methods, and audit readiness.

Qualifications

• Bachelor degree in IT/CS/Engineering or equivalent.
• 5–10 years in software testing, quality engineering, validation, or verification in regulated environments.
• Strong understanding of SDLC, testing principles, and validated environments.

Responsibilities

• Lead validation activities for study software per SOPs, GCP, and regulatory expectations.
• Review and approve CSV packages, tests, defects, and supporting materials.
• Design, execute, review, and document functional, integration, regression, and performance tests.
• Coordinate with developers and stakeholders to understand requirements, changes, risks, and mitigations.
• Manage test environments, provide status updates, and support audits and inspections.

Skills

Test management

Test design

Automation testing

Regulated validation

Education

Bachelor of Technology in IT/CS/Engineering

ISTQB Advanced Level Test Analyst (preferred)

Tools

Bug tracking systems

Test management systems

Document management systems

Screenshot tools

Test automation suites

Job description

## Sr Software Quality Engineer (V&V)Applylocations: Bangalore, Indiatime type: Full timeposted on: Posted Todayjob requisition id: R17961At 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.**What We Offer*** Competitive pay and incentives* Provident fund and medical insurance* Engaging employee programs and local events* Modern office spaces and remote work flexibility**What You’ll Be Doing*** 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.**What We Look For*** 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.