Senior Validation Specialist
3 semanas atrás
At Capgemini Engineering, a global leader in engineering services, we bring together a talented team of engineers and scientists to help the world's most innovative companies unlock their potential.
About the RoleWe are seeking an experienced Computer System Validation (CSV) Specialist to join our team in the Life Sciences sector. The ideal candidate will have extensive experience in validating Manufacturing Execution Systems (MES) and Laboratory Information Management Systems (LIMS).
This role will be critical in ensuring compliance with regulatory requirements, maintaining the integrity and reliability of our computerized systems, and supporting the development of cutting-edge technologies.
Your Profile- Proven experience in CSV within the Life Sciences industry;
- Extensive knowledge of MES and LIMS systems;
- In-depth understanding 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;
- Multicultural and inclusive team environment;
- Supportive atmosphere promoting work-life balance;
- Hybrid work arrangement;
- Career growth opportunities through diverse professionals and programs;
- Access to valuable training and certifications in cutting-edge technologies;
- National and international projects;
- Health and life insurance benefits;
- Referral program with bonuses for talent recommendations;
- Great office locations;
Choosing Capgemini means choosing a company where you will be empowered to shape your career in the way you'd like, supported by a collaborative community of colleagues around the world, and inspired to reimagine what's possible.
We help the world's leading organizations unlock the value of technology and build a more sustainable, more inclusive world.
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