Life sciences Computer System Validation Engineer

About the Position

Life sciences Computer System Validation Engineer

Machelen, Vlaams Gewest, Belgium

Sopra Steria offers tailored, end-to-end corporate technology and software solutions to help clients make bold choices and deliver results. Successfully so! With more than 51.000 colleagues in 30 countries, we rank as Europe’s leading digital solutions provider. Some of the most successful companies in Europe rely on our technology due to our commitment to innovation, collaboration, and value in business development.

The world is how we shape it. Let’s shape it together.

As a quality and compliance expert, you will be responsible for ensuring that GxP systems and processes adhere to the applicable regulatory requirements throughout the entire system lifecycle. Therefore, you stay up to date about evolving regulations from authorities such as the EMA and FDA and industry standards like GAMP and ISO. Depending on your role and expertise, you may be asked to provide Quality & Compliance support during audits and inspections, or to join a Sopra Steria validation service team.

As a trusted Computerized System Validation (CSV) Engineer, you play a key role in the validation process of the computerized systems used by our clients in the Life Sciences sector. More specifically, your mission is to ensure the quality and regulatory compliance of GxP systems throughout their entire life cycle and across all GxP areas (GLP, GCP, GMP, GDP, GPvP). Systems in scope can include site-specific lab instruments (e.g. HPLC software) and production equipment (e.g. capsule filling machine), but also globally used web applications, Clinical Trial Management Systems, complex Manufacturing Execution Systems, SAP systems, medical devices, etc…

We’re seeking passionate colleagues who are eager to push the boundaries in digital transformation and technology consulting. At Sopra Steria, you’ll have the opportunity to grow your skills in a constructive, collaborative team environment, working on impactful projects that drive change for our clients. If you thrive on challenge and meet (most of) the qualifications below, we look forward to your application!

Responsibilities

• Ensure GxP systems adhere to regulatory requirements throughout their lifecycle.
• Stay updated on evolving regulations from authorities such as the EMA and FDA.
• Provide Quality & Compliance support during audits and inspections.
• Join a Sopra Steria validation service team as needed.

Requirements

• Proven CSV experience in multiple projects or 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 Dutch and 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.

We Offer

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

About the Company

Sopra Steria is an equal opportunity employer. All qualified applicants will be considered for employment without regard to age, ancestry, nationality, 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 applicable local laws, regulations and ordinances. We foster a work environment that is inclusive and respectful of all differences.

Ready to take the next step? We’re here to support you all the way and we are looking forward to your application!