Validation Engineer

4 weeks ago

Bangalore, India Danaher Full time

#LI-VK1

Be part of something altogether life-changing

Working at Cytiva in the Life Sciences industry means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.

At Cytiva you will be able to continuously improve yourself and us â working on challenges that truly matter with people that care for each other, our customers, and their patients. With associates across 40 countries, Cytiva is a place where every day is a learning opportunity â so you can grow your career and expand your skills in the long term.

Cytiva is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, weâre pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.

We are looking for a Validation Engineer to work with our expert Information Technology team across the world.  Do you have a passion for computer systems validation management?  Then we would love to hear from you.

In this role, you will have the opportunity to:

Work with the Computer Systems Validation Managers and QA to support the Computer Systems Validation Activities across Cytiva.  You will have a good understanding in validation and worked in the successful validation of systems.

  • Work with the Validation Managers and QA to implement regulated non-product software Validation Plans following the approach to perform the required validation activities and deliver the deliverables, acceptance criteria.

  • Create and Approve validation deliverables as required by Cytiva QMS, regulatory compliance and any specific validation plan requirement.

  • Support change control process from Assessing change control validation impact through closure including approval and authorization for move into production.

  • Partner with QA to develop any specific work instructions required to support validation activities whether associated or not with software used to support validation activities.

  • Communicates solutions, validation status with cross functional partner organizations.

The essential requirements of the job include:

  • Minimum 1 yearsâ experience computerized system testing or Validation activities 

  • Experience working with virtual teams on a global basis.

  • FDA or other regulatory compliance knowledge is advantageous.

  • Strong communication skills in English

  • Quality minded â must be focused on, and capable of, delivering high quality outcomes.

  • Inclusiveness â demonstrated ability to work well IT and Functional Teams and with people at all levels of the organization.

  • Logical thinking â can deal with ambiguity effectively in order to create logical, structured and credible test plans/strategies.

  • Pragmatism/creativity â Is passionate about quality and the value it brings / role it plays in IT and is able to think creatively and pragmatically in order to ensure that value is applied in the most effective way.

At Cytiva we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part-time at the Company location identified above and part-time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Cytiva can provide.

At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrowâs 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. Our global teams are pioneering whatâs next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

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