Senior / Expert CSV Engineer (M/F) - Lisboa

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 (from 6 years)

Strong knowledge of GxP regulations and guidelines;

Strong verbal and written communication skills in English (at least B2).

Experience with MES or LIMS

 

 

 

Nice-to-have:

Knowledge in ISO 13485, ISO 19471 and/or EN 62304;

Verbal and written communication skills in French.

 

 

 

What we offer:

Our famous atmosphere:

There’s always someone happy to start a day with a cup of coffee with you – even virtually! We are a big company with unique atmosphere – we make friendships, share important moments, and… simply like each other!

 

 

 

A lot of benefits:

· Private medical care

· Referral bonuses for recommending your friends to Capgemini.

· Offices in great locations

· Participation in a international projects

· Integration in a multinational company

· Career Evolution