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 MFG SW Validation Lead position that supports quality systems activities related to Instrument manufacturing software validation, with a focus on production and process controls and risk management in accordance with FDA and ISO regulations. This position contributes to the completion of milestones associated with Systems projects and activities using existing procedures.
This position is part of the Quality department and will be located in the India Development Center, Bengaluru, India. The Quality department collaborates with cross-functional business partners to ensure that customer needs and safety are met, government regulations and quality requirements are effectively monitored, measured, maintained and continuously improved.
In this role, you will have the opportunity to:
- Serve as technical lead on System core teams to define quality deliverables and ensure compliance with validation and risk‑management requirements
- Define validation strategies and lead execution of validation activities in accordance with regulated manufacturing software and system requirements
- Draft validation plans, protocols, test designs, and validation reports aligned with SOPs and system lifecycle documentation
- Collaborate with Engineering core teams to identify, troubleshoot, and resolve manufacturing software issues encountered during validation
- Conduct formal safety and security risk assessments per SOPs and drive updates to test protocols and validation processes based on evolving business and system needs
The essential requirements of the job include:
- BE/BS degree or equivalent work experience in Biotechnology, Biology, Biomedical Engineering, Mechanical or Electrical Engineering, Software Engineering, or related field with 7+ years of system validation or software validation testing experience in regulated environments
- Demonstrated understanding of FDA and ISO regulatory frameworks, including process controls, risk management, and software validation requirements
- Proficiency in Windows environments, web application testing, and SQL, including ability to run queries and interpret results
- Experience completing validation activities across multiple product release cycles within FDA/ISO‑regulated product development lifecycles
- Experience leading risk assessment activities using tools such as FMEA and supporting small‑scope validation or testing projects with defined risk and resource parameters
It would be a plus if you also possess previous experience in:
- Quality Engineering certification from American society for quality (ASQ) or other qualifying organizations such as CRE, CQA
- Experience working with software tools such as Agile, Complaint tracking, requirements management, defect tracking systems
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 Danaher Benefits Info.
This job is also eligible for bonus/incentive pay. We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.
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.
