Job Description
A Validation Engineer role is available to design and build a program to monitor and review computerised systems, ensuring compliance to regulatory requirements and corporate standards.
Location: Ireland, Waterford
Hiring Manager: Caroline MURPHY
Target start date: 01/01/2025
i Move, the Sanofi VIE Program, is available to citizens of the European Economic Area (EU + Norway, Liechtenstein and Iceland) aged between 18 and 28.
Candidates cannot apply to a VIE assignment in their own country of citizenship.
Only applications submitted in English will be considered.
About the role
As a Validation Engineer VIE, you will develop knowledge to design and build a program to monitor and review all sites computerised systems (CS), ensuring that the CS remain in a validated state.
This includes compliance to regulatory requirements, corporate and site standards and procedures.
Main responsibilities:
- Develop a deep understanding for computer system validation and qualification.
- Develop knowledge to monitor and review computerised systems (CS), ensuring that the CS remain in a validated state.
- Design and build validation plans for computerised 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.
- Develop reporting skills to record and inform on outcomes of Commissioning, Qualification and Validation activities.
- Develop knowledge of GAMP 5 categorisation of computerised systems and apply this knowledge spanning across Enterprise systems to standalone systems and computerised equipment.
About you
Experience:
- Within development and manufacturing industries and 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.
Education:
- Master's degree in computer science, engineering, electronics, or related field.
Languages:
- Fluent English.
About Sanofi
i Move 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.
We provide those opportunities in various functions such as: marketing, finance, regulatory, supply chain, clinical trials, production, etc.
We unite people who are passionate about solving healthcare needs across the world.
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.