Life Sciences Computer system validation engineer

About the Position

Life Sciences Computer System Validation Engineer

Brussel, Vlaams Gewest, Belgium

Sopra Steria offers tailored technological and software solutions to help clients make bold choices and achieve successful results. With over 51,000 employees in 30 countries, we are the European leader in digital solutions. Many of Europe's most successful companies trust our technology due to our commitment to innovation, collaboration, and value creation in business development.

The world is shaped by us. Let's shape it together.

As a quality and compliance expert, you will be responsible for ensuring that GxP systems and processes meet applicable regulatory requirements throughout their lifecycle. To do this, you will stay informed about regulatory developments from authorities such as the EMA and FDA, as well as industry standards such as GAMP and ISO. Depending on your role and expertise, you may be involved in providing Quality & Compliance support during audits and inspections, or joining a Sopra Steria validation team.

As a trusted Computer System Validation (CSV) engineer, you play a key role in the validation process of IT systems used by our clients in the life sciences sector. Specifically, your mission is to ensure the quality and regulatory compliance of GxP systems throughout their lifecycle, in all GxP domains (GLP, GCP, GMP, GDP, GPvP). The systems involved may include site-specific laboratory instruments (e.g., HPLC software) and production equipment (such as a capsule filling machine), as well as web applications used globally, clinical trial management systems, complex production execution systems (MES), SAP systems, medical devices, etc.

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Responsibilities

• Ensure quality and regulatory compliance of GxP systems throughout their lifecycle
• Stay informed about regulatory developments and industry standards
• Provide Quality & Compliance support during audits and inspections
• Collaborate with Sopra Steria validation teams

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Requirements

• Confirmed experience in CSV in multiple projects or strong interest in computer system validation
• Strong affinity with IT
• Analytical and pragmatic mindset
• Solid skills in planning and priority management
• Strong sense of responsibility and commitment
• Positive, solution-oriented attitude
• Excellent written and oral communication skills in Dutch and English
• Basic knowledge of IT infrastructure qualification
• Team spirit, with the ability to work independently
• Familiarity with regulatory standards and guidelines (21 CFR Part 11, EU Annex 11, GDPR, GAMP5, ISO 9001, etc.) and concepts such as QMS, CAPA, data integrity, etc.
• Familiarity with the application of validation methodologies (Waterfall, Agile) in a GxP environment

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We Offer

• A variety of benefits, including mobility options (including a company car), insurance coverage, meal vouchers, eco-vouchers, and more
• Continuous learning opportunities through the Sopra Steria Academy to support your professional development
• The opportunity to connect with Sopra Steria colleagues at various team events

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About the Company

Sopra Steria is an employer that promotes equal opportunities. All qualified candidates are considered for employment without regard to age, ancestry, national origin, color, family or medical leave, gender identity or expression, genetic information, immigration status, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran or military status, race, ethnicity, religion, gender (including pregnancy), sexual orientation, or any other characteristic protected by local laws, regulations, and ordinances. We foster an inclusive and respectful work environment that values diversity.

Ready to take the next step? We are here to support you every step of the way and look forward to your application!