BE - Computer System Validation Specialist (CSV Specialist)

Overview:

Who are we?

Collaboration Betters The World (CBTW), is a company providing tech et business solutions to its clients, through the expertise of its 9 service lines.

As a CSV engineer you will join our Life Science Solution service line, where we are providing comprehensive support in Quality Assurance and Industrialization to revolutionize the Healthcare and Medical Devices sectors.

For the client impact, tasks can vary depending on the client and the project.

Responsibilities:

What will you do ?

As a CSV Engineer, you will mainly:

• Ensure the readability and traceability of data (data integrity).
• Work on automated and computerized systems in the context of installing new equipment, modifying existing equipment, and conducting periodic validation.
• Validate production and laboratory systems (PLC and HMI), as well as SCADA supervision and other computerized systems.
• Ensure audit trail, access management, backup, and restoration.
• Manage the implementation of a Validation Master Plan.
• Draft protocols and reports.

Qualifications:

• Hold a master’s degree or a bachelor’s degree with equivalent experience.
• Minimum 2 years of experience in Qualification& Validation in the pharmaceutical sector.
• Knowledge of the regulatory framework related to the healthcare industry (ISO, GMP, GLP, GMP, etc.).
• You train operators and technicians before transferring installations to production.
• Native French or Dutch speaker, and professional proficiency in English.

What are we offering?

Evolution:

• Personal follow-up during your career at CBTW and buddy-ship program during your first 6 months.
• Catalogue with a wide variety of trainings for hard & soft skills, private language classes, unlimited access to an E-learning platform (Udemy, LifeCycle,…) and possibility to get certified every year.

Collaboration:

• On top of the Product Design community, you can join one of the passion communities and practice your hobby or share your interests with other positive thinkers.
• International collaboration, possibility to work worldwide.

On top of that:

• Competitive salary with a flexible mobility package (variety of choice between electric cars, electric bikes, payment of rent/mortgage...).
• You will become part of a growing team of people keen on applying the latest technologies and knowledge. You will be able to work in a dynamic, innovative environment.

Do you see a match? We would love to see your application coming in! 😉