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Life Sciences Computer System Validation Engineer

https://www.soprasteria.com Logo

Sopra Steria

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Location:
Belgium

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Category:
IT - Administration

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Contract Type:
Employment contract

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Salary:

Not provided

Job Description:

As a V.I.E. in the Life Sciences division, you will support the validation and compliance of computerized systems used in regulated environments, ensuring that GxP systems meet regulatory standards. You’ll contribute to audits, stay informed on evolving regulations (EMA, FDA, GAMP, ISO), and work closely with Sopra Steria’s validation service teams. This position offers the opportunity to gain international experience and collaborate with industry experts.

Job Responsibility:

  • Support the validation and compliance of computerized systems used in regulated environments
  • ensure GxP systems meet regulatory standards throughout their lifecycle
  • contribute to audits
  • stay informed on evolving regulations (EMA, FDA, GAMP, ISO)
  • work closely with Sopra Steria’s validation service teams.

Requirements:

  • Strong interest in CSV
  • strong affinity with IT
  • analytical and pragmatic thinking skills
  • strong prioritization and planning skills
  • strong sense of responsibility and accountability
  • a positive, solution-driven mindset
  • excellent written and oral communication skills in English
  • basic knowledge of IT infrastructure qualification
  • a team player, but also able to work independently
  • familiar with applicable regulatory standards and guidelines (21CFR Part 11, EU Annex 11, GDPR, GAMP5, ISO 9001,...) and concepts such as QMS, CAPAs, Data Integrity,...
  • familiar with applying validation methodologies (Waterfall, Agile) within a GxP environment.
What we offer:
  • An international experience: be part of an innovative company with global reach
  • a stimulating environment: work on ambitious projects and collaborate with industry experts
  • a dynamic company culture: join a human-sized team within a large group
  • career growth opportunities: potential for long-term career development in Canada or within the Sopra Steria Group.

Additional Information:

Job Posted:
May 27, 2025

Employment Type:
Fulltime
Work Type:
On-site work
Job Link Share:
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