QA MFG SW Validation Professional

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 Professional is responsible to support MFG SW validation activities related to instrument manufacturing software development with focus on production and process controls in accordance with FDA and ISO regulations.  

This position is part of the Quality department and will be on-site role and 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:

• Perform duties as an individual contributor and/or team member with 100% hands-on work.

  
  

• Prepare and manage key validation documents, including Validation Plans, risk assessments, protocols, test plans, and reports. Ensure that these documents are compliant with internal and external standards.

  
  

• 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 software 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 or related field.

  
  

• 4+ years of Software Validation testing experience in a regulated environment.

  
  

• Understanding of US FDA 21 CFR Part 11, EU Annex 11, GAMP 5 and ISO regulations. e.g., design controls, risk management, and software validation.

  
  

• Self-motivated, willing to learn new concepts, technologies, and products quickly.

  
  

• Excellent interpersonal, writing and communication skills, and troubleshooting skills. Passionate about testing, product quality, and customer satisfaction.

  
  

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

• Software development life cycle (SDLC) methodologies (e.g., Waterfall, Agile) and experience working with different system types such as Laboratory Information Management Systems (LIMS), Manufacturing Execution Systems (MES), or Enterprise Resource Planning (ERP) systems.

  
  

• 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 atDanaher Benefits Info.

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.