Computer System Validation Specialist

Há 1 mês


Lisboa, Lisboa, Portugal Capgemini Tempo inteiro

We are seeking a skilled and experienced Computer System Validation Specialist to join our team in the Life Sciences sector. The ideal candidate will have extensive experience in the validation of Manufacturing Execution Systems (MES) and Laboratory Information Management Systems (LIMS).


About the Role


The Computer System Validation Specialist will be critical in ensuring compliance with regulatory requirements and maintaining the integrity and reliability of our computerized systems. This includes:



  • Experience in Computer System Validation (CSV) within the Life Sciences industry;
  • Proven experience with MES and LIMS systems is essential;
  • In-depth knowledge of regulatory requirements such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines;
  • Strong analytical and problem-solving skills, with the ability to conduct thorough risk assessments and impact analyses;
  • Excellent documentation skills and attention to detail;
  • Good command of English.

About Capgemini


Choosing Capgemini means choosing a company where you will be empowered to shape your career in the way youd like, where youll be supported and inspired by a collaborative community of colleagues around the world, and where youll be able to reimagine whats possible. Our team is dedicated to helping the worlds leading organizations unlock the value of technology and build a more sustainable, more inclusive world.



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