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Computer System Validation Engineer

4 meses atrás

Lisbon, Portugal Capgemini Tempo inteiro

At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world’s most innovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as they provide unique R&D and engineering services across all industries. Join us for a career full of opportunities. Where you can make a difference. Where no two days are the same.

YOUR ROLE

We are seeking a skilled and experienced Computer System Validation (CSV) Consultant to join our team in the Life Sciences sector. Experience in the validation of Manufacturing Execution Systems (MES) and Laboratory Information Management Systems (LIMS) is a plus. This role will be critical in ensuring compliance with regulatory requirements and maintaining the integrity and reliability of computerized systems.

YOUR PROFILE
  • Experience in Computer System Validation (CSV) within the Life Sciences industry;
  • Experience with MES and LIMS systems is a nice-to-have;
  • 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.
WHAT YOU’LL LOVE ABOUT WORKING HERE
  • Join a multicultural and inclusive team environment.
  • Enjoy a supportive atmosphere promoting work-life balance.
  • Hybrid work.
  • Your career growth is central to our mission. Our array of career growth programs and diverse professionals are crafted to support you in exploring a world of opportunities.
  • Access valuable training and certifications in cutting-edge technologies.
  • Engage in exciting national and international projects.
  • Health and life insurance.
  • Referral program with bonuses for talent recommendations.
  • Great office locations.
ABOUT CAPGEMINI

Choosing Capgemini means choosing a company where you will be empowered to shape your career in the way you’d like, where you’ll be supported and inspired by a collaborative community of colleagues around the world, and where you’ll be able to reimagine what’s possible. Join us and help the world’s leading organizations unlock the value of technology and build a more sustainable, more inclusive world.