الوصف الوظيفي
Be part of something altogether life-changing!Working at Cytiva 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 – 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 – so you can grow your career and expand your skills in the long term.Forming part of the Biotechnology segment at Danaher, we bring together dedicated technical expertise and talent to develop the next generation of life-changing therapeutics.The IT Validation Manager for Cytiva is responsible for the Computer Systems Validation activities (non-product software) for the assigned systems across Cytiva.This position is part of the Information Technology department located in Bangalore, India and will be on-site. At Cytiva, our vision is, to advance future therapeutics from discovery to delivery.In this role, you will have the opportunity to :Develop validation strategies partnering with QA and create validation plans.Execute the 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.Support internal and external audits, Regulatory inspections by providing documentation and evidence of validation activities as required.The essential requirements of the job include :Degree educated with a STEM subject.Minimum 3 years’ experience in computerized system validation as Validation or Quality Representative.Good understanding of GAMP5 guidelines and Regulatory requirements including 21 CFR Part 11, EU Annex 11Strong communication skills in EnglishExperience working with virtual teams on a global basis.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. 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.
