Company We are Capgemini Engineering.
A brand part of the Capgemini Group.
We have the mission to empower every person and every organization on the planet to achieve more.
Our culture is centered on embracing a growth mindset, diversity, inclusion, a purpose of inspiring excellence, and encouraging teams and leaders to bring their best each day.
In doing so, we create life-changing innovations that impact billions of lives around the world.
You can help us to achieve our mission !
Now, we have more than 270,000 team members in nearly 50 countries, in sectors such as aeronautics, automotive, communications, energy, life sciences, software & internet, space & defense and consumer products.
About the Job We're seeking a partner who shares knowledge, responsibility and commitment in the execution of activities related with the day-to-day business activity, namely in the CSV/QA area.
This position is open for Lisbon, Porto & Fundão.
Profile Your role: Perform as a CSV engineer supporting computerized system validation and IT qualification of applications and software; Anticipate and advise about GxP-regulated and regulatory compliance computerized validation processes needs based on each system specifications; Perform QA activities supporting Medical Devices software development projects; Perform end-to end validation to verify software (validation planning, test protocols and reports, risk assessments); Work within a team with specific roles following regulations and guidelines interacting with other teams and stakeholders; Share knowledge about computerized system validation and medical devices.
Your profile: Academic degree in biomedical engineering, pharmaceutical sciences, IT or computer science or related fields; Previous experience in computerized system validation – CSV, ideally 2 to 5 years; Strong knowledge of GxP regulations and guidelines; Solid verbal and written communication skills in English (at least B2).