Life Sciences Computer system validation engineer

Role Summary

As a quality and compliance expert, you will be responsible for ensuring that GxP systems and processes meet applicable regulatory requirements throughout their lifecycle. You do this by staying up to date with 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 required to provide Quality & Compliance support during audits and inspections, or to join a Sopra Steria validation team.

As a trusted Computerized Systems Validation (CSV) Engineer, you play a key role in the validation process of computerized systems used by our clients in the life sciences sector. More precisely, your mission is to guarantee the quality and regulatory compliance of GxP systems throughout their life cycle, in all GxP domains (GLP, GCP, GMP, GDP, GPvP). Affected systems may include site-specific laboratory instruments (e.g. HPLC software) and production equipment (such as a capsule filling machine), but also globally used web applications, clinical trial management systems, complex production execution systems (MES), SAP systems, medical devices, etc.

Requirements

We are looking for passionate colleagues who want to push the boundaries of digital transformation and technology consulting. At Sopra Steria, you will have the opportunity to develop your skills in a constructive and collaborative team environment, working on high-impact projects that bring real change for our clients. If you like challenges and meet (mostly) the qualifications below, we look forward to your application!

• Proven experience in CSV in several projects or strong interest in validating computerized systems
• Strong affinity with IT
• Analytical and pragmatic mind
• Strong planning and priority management skills
• 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, while being able to work independently
• Knowledge of applicable regulatory standards and guidelines (21 CFR Part 11, EU Annex 11, GDPR, GAMP5, ISO 9001, ...) as well as concepts such as QMS, CAPA, data integrity, ...
• Familiarity with the application of validation methodologies (Waterfall, Agile) in a GxP environment

Benefits

Are you ready to take your career to the next level? Then we would be happy to help you take the right direction. With offices in over 30 countries, this direction could take you to places you've never been before. Do you prefer to evolve internally? It’s entirely possible too. We challenge you to keep pushing yourself to become the best version of yourself.

We offer an attractive benefits package for employees, including

• A variety of benefits, such as mobility options (including a company car), insurance coverage, meal vouchers, eco-vouchers, and much more.
• Continuous learning opportunities via the Sopra Steria Academy to support your professional development.
• The opportunity to connect with your Sopra Steria colleagues during various team events.
• Ready to take the next step? We are here to support you every step of the way and we look forward to your application!
• ______
• Sopra Steria is an equal opportunity employer.

All qualified applicants 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, veteran or protected military status, race, ethnicity, religion, gender (including pregnancy), sexual orientation or any other feature protected by applicable local laws, regulations and ordinances. We promote a work environment that is inclusive and respectful of all differences.

About the Company

Sopra Steria offers tailor-made, end-to-end technology and software solutions to help its clients make bold choices and achieve results. And this, with success! With more than 51,000 employees in 30 countries, we are the European leader in digital solutions. Some of Europe's most successful companies trust our technology thanks to our commitment to innovation, collaboration and value creation in business development.

The world is as we make it. Let’s shape it together.