QA Validation Professional (CSV/Product Software Validation)

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 position that supports 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 is part of the Cepheid Quality Team and will be located at Danaher India Development Center (IDC), Bengaluru, Onsite. At Cepheid, our vision is to be the leading provider of seamlessly connected diagnostic solutions

In this role, you will have the opportunity to:

• Responsible for the validation of Product Software Systems/ Computer Systems. Perform duties as an individual contributor and/or team member with 100% hands-on work

• Create and update validation deliverables, provide and analyze test data, and drafts of validation report. Generate and update traceability matrices and quality metrics. Ensure that these documents are compliant with internal and external standards. Also, Write, execute, and update test protocols in accordance with SOPs.

• Record, report, and verify software defects to accurately depict the software requirements also work closely with Software Engineering team toward the reporting and resolution of design issues and/or software defects.

• Create change orders in document control system. Conduct test design reviews and risk assessments with core team members, influences key stakeholders to drive quality improvements.

• Participate in product validation to ensure the software meets user needs requirements of user workflows for a regulated environment.

The essential requirements of the job include

• BE/BS degree or equivalent work experience in Computer Science, Biology, Biomedical Engineering, or a related field

• 3+ years of experience in Computer System Validation or Product Software Validation testing within a regulated environment, with a strong understanding of FDA and ISO regulations (e.g., design controls, risk management, and software validation).

• Experience with: Windows environments, Web application testing, and working knowledge of SQL, including the ability to run queries, and interpret results.

• Excellent analytical and troubleshooting skills; self-motivated and eager to learn new concepts, technologies, and products quickly. Strong interpersonal, written, and communication skills, along with a commitment to quality software and customer satisfaction.

• Ability to train and mentor colleagues with less experience; capable of leading small projects with manageable risks and resource requirements.

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

• Experience with ISO 13485 and risk assessments per ISO 14971, with completing major projects across multiple release cycles. Must have working knowledge of the software development lifecycle in FDA/ISO or other regulated environments

• Involved in implementing AI/ML and Cloud solutions.

Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at danaherbenefitsinfo.com.

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.