QA Validation Professional – P2

Danaher Corporation; Bengaluru; On-site; INR 1,200,000 - 2,400,000; Full time

Job summary

Cepheid, part of Danaher, seeks a QA Validation professional to support software validation with a focus on design controls and risk management. You’ll contribute to milestones for software projects from a hands‑on role and collaborate with Software Engineering and cross‑functional teams.

You will ensure compliance with FDA/ISO requirements, develop validation deliverables, and drive quality improvements in a fast‑paced environment at our Bengaluru site.

Qualifications

• 3+ years in Computer System Validation (CSV) or Product Software Validation in regulated settings.
• Strong understanding of FDA, 21 CFR Part 11, EU Annex 11, GAMP 5, ISO standards and risk management.
• Hands‑on validation/testing with Windows, web apps, SQL and validation deliverables.

Responsibilities

• Validate Product Software Systems, including planning, execution, review and documentation of validation activities.
• Create, review and manage Validation Master Plans, risk assessments and validation reports.
• Design, execute and review functional, integration and user acceptance testing (UAT).
• Record, investigate and report software defects; work with Engineering to resolve issues.
• Manage document changes, conduct design reviews and support Product Lifecycle activities.

Skills

Regulatory knowledge

Validation leadership

Communication

Analytical skills

Problem solving

Education

BE/BS in Computer Science or related field

Tools

Windows

SQL

Defect tracking

Job description

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

At Cepheid, one of Danaher’s 15+ operating companies, our work saves lives-and we’re all united by a shared commitment to innovate for tangible impact.

You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.

At Cepheid, we are passionate about improving health care through fast, accurate, molecular diagnostic systems and tests. As a member of our team, you’ll get to make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Our mission drives us to develop groundbreaking solutions for the world’s most complex health challenges. Together, we bring more change to the world.

Learn about the Danaher Business System which makes everything possible.

The QA Validation Professional is responsible for supporting the quality systems activities related to software validation, with a focus on design control and risk management in accordance with FDA and ISO regulations. This position contributes to the completion of milestones associated with software projects and activities using existing procedures. This position requires a moderate level of guidance and direction and can solve problems and analyze possible solutions using technical experience.

This position reports to the Associate QA Manager and is part of the Cepheid - Software Test Engineering - QA located in IDC, Bengaluru and will be an on-site role.

In this role, you will have the opportunity to:

• + Responsible for the validation of Product Software Systems and Computer Systems, including the planning, execution, review, and documentation of validation activities. Perform duties as an individual contributor and/or team member with 100% hands‑on work.
• + Create, review, and manage validation deliverables including Validation Master Plans (VMPs), risk assessments, protocols, test plans, traceability matrices, and validation reports. Ensure compliance with internal procedures and applicable regulatory requirements.
• + Design, document, execute, and review functional, integration, and user acceptance testing (UAT) activities. Analyze test results, generate validation evidence, and support validation report completion in accordance with SOPs.
• + Record, investigate, verify, and report software defects to ensure accurate representation of software requirements and support timely resolution of design and implementation issues. Work closely with Software Engineering and cross‑functional teams to support the identification, resolution and verification of design issues and software defects.
• + Manage documentation changes through the document control system, conduct test design reviews and risk assessments, support Product Lifecycle Application Management activities, drive quality improvements through stakeholder collaboration, and actively participate in daily management using DBS tools.

The essential requirements of the job include:

• + BE/BS degree or equivalent work experience in Computer Science, Biology, Biomedical Engineering, or a related field, with 3+ years of Computer System Validation (CSV) and/or Product Software Validation experience in a regulated environment.
• + Strong understanding of regulatory and quality requirements, including FDA regulations, 21 CFR Part 11, EU Annex 11, GAMP 5, ISO standards, design controls, risk management, and software validation principles.
• + Hands‑on experience with validation and testing activities, including Windows environments, web application testing, SQL query execution and analysis, troubleshooting, defect management, and validation deliverable development.
• + Excellent communication, analytical, and leadership skills, with the ability to quickly learn new technologies, drive product quality and customer satisfaction, mentor less experienced team members, and independently lead small to medium validation projects.

It would be a plus if you also possess previous experience in:

• + Software Development Life Cycle (SDLC) methodologies (Agile, Waterfall) and validation of systems such as LIMS, MES, ERP, Cloud, or enterprise software platforms.
• + Computer Software Assurance (CSA) implementation, risk‑based validation approaches, and transition from traditional CSV practices to CSA methodologies.
• + AI/ML‑enabled applications, cloud‑based solutions, Product Lifecycle Management (PLM/ALM) systems, and participation in regulatory inspections or quality audits as a validation subject matter expert.

Join our winning team today. Together, we’ll accelerate the real‑life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com .

Operating Company: Cepheid