Validation Engineer - VIE ContractLocation: Ireland, Waterford
Hiring Manager: Caroline MURPHY
Target start date: 01/01/2025
About the job Looking to launch your career at the cutting edge of healthcare? Join Sanofi for a chance to develop with mentoring and guidance from inspirational leaders while helping to make an impact on the lives of countless people worldwide. As a Validation Engineer VIE in our Engineer team, you will develop knowledge to design and build a program to monitor and review all sites' computerized systems (CS), ensuring that the CS remain in a validated state. This includes compliance with regulatory requirements, compliance with corporate and site standards and procedures.
We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.
Main responsibilities: Develop a deep understanding of computer system validation and qualification.Develop knowledge to monitor and review computerized systems (CS), ensuring that the CS remain in a validated state. This includes compliance with regulatory requirements, compliance with corporate and site standards and procedures.Design and build validation plans for computerized systems from the concept phase of a project through to the end of life of a system.Contribute within an agile team to support Commissioning, Qualification, and Validation activities in close collaboration with cross-functional departments such as Engineering, Manufacturing, Quality, Automation, and Project Management.Develop reporting skills to record and inform on outcomes of Commissioning, Qualification, and Validation activities.Develop knowledge of GAMP 5 categorization of computerized systems and apply this knowledge spanning across Enterprise systems to standalone systems and computerized equipment.About you Experience: Experience within development and manufacturing industries; ideally biopharma would be a plus; experience with Good Manufacturing Practice (GMP) is a plus.Soft and Technical skills: Familiarity with computer software installations is a plus.Demonstrated "get-things-done" mindset.Problem-solver with the ability to find creative ways to overcome roadblocks and keep the wheels running.Ability to work to timelines and goals.Ability to work in cross-cultural environments.Ability to break down complex topics without prior domain knowledge.Comfortable working with cross-functional teams consisting of a different mix of stakeholders, including business leaders, engineers, manufacturing scientists, data scientists, IT specialists, and business analysts, through an adaptive communication style.Education: Master's degree in computer science, engineering, electronics, or related field.Languages: Fluent English.Why choose us? iMove is a unique program tailored for European youth interested in challenging themselves with meaningful assignments across the globe. At Sanofi, we have a strong ambition to invest in young talents who will drive the success of Sanofi tomorrow.
Sanofi's Work Abroad Program, iMove, offers jobs-assignments with actual responsibilities and a perspective to grow. We provide those opportunities in various functions such as marketing, finance, regulatory, supply chain, clinical trials, production, etc. and in more than 40 countries. Sanofi unites people who are passionate about solving healthcare needs across the world. Joining our iMove Work Abroad Program is a unique opportunity to make a difference through your work.
Pursue Progress. Discover Extraordinary.
Progress doesn't happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas, and exploring all the opportunities we have to offer. Let's pursue progress. And let's discover extraordinary together.
At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com.
Why SanofiAs an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
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