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CSV Specialist
Functieomschrijving
Our client is a dynamic company dedicated to providing innovative technology and business solutions that empower clients across various sectors. With a strong focus on the Life Sciences field, they offer comprehensive support in Quality Assurance and Industrialization, aiming to revolutionize the Healthcare and Medical Devices industries.
As a CSV Engineer, you will play a crucial role in ensuring data integrity and compliance while making a meaningful impact on both clients and the internal team. You will have the opportunity to engage with our client's internal Life Science Community, sharing knowledge and best practices that contribute to professional growth and innovation.
Key Responsibilities:
Ensure readability and traceability of data, maintaining data integrity.
Work with automated and computerized systems for installing new equipment, modifying existing systems, and conducting periodic validation.
Validate production and laboratory systems, including PLC, HMI, SCADA, and other computerized systems.
Oversee audit trails, access management, and backup/restore processes.
Manage the implementation of a Validation Master Plan.
Draft protocols and reports in compliance with regulatory standards.
As a CSV Engineer, you will play a crucial role in ensuring data integrity and compliance while making a meaningful impact on both clients and the internal team. You will have the opportunity to engage with our client's internal Life Science Community, sharing knowledge and best practices that contribute to professional growth and innovation.
Key Responsibilities:
Ensure readability and traceability of data, maintaining data integrity.
Work with automated and computerized systems for installing new equipment, modifying existing systems, and conducting periodic validation.
Validate production and laboratory systems, including PLC, HMI, SCADA, and other computerized systems.
Oversee audit trails, access management, and backup/restore processes.
Manage the implementation of a Validation Master Plan.
Draft protocols and reports in compliance with regulatory standards.
Profiel
Essential Qualifications:
Master's degree or bachelor's degree with equivalent experience.
Initial experience in Computer System Validation (CSV).
Strong organizational, interpersonal, and communication skills.
Ability to manage cross-functional projects effectively.
Familiarity with regulatory frameworks relevant to the healthcare industry (ISO, GMP, GLP).
Proficiency in validation stages (URS/DQ/IQ/OQ/PQ).
In-depth knowledge of 21 CFR Part 11, Annex 11, and GAMP 5.
Native French or Dutch speaker with professional proficiency in English.
Master's degree or bachelor's degree with equivalent experience.
Initial experience in Computer System Validation (CSV).
Strong organizational, interpersonal, and communication skills.
Ability to manage cross-functional projects effectively.
Familiarity with regulatory frameworks relevant to the healthcare industry (ISO, GMP, GLP).
Proficiency in validation stages (URS/DQ/IQ/OQ/PQ).
In-depth knowledge of 21 CFR Part 11, Annex 11, and GAMP 5.
Native French or Dutch speaker with professional proficiency in English.
Aanbod
What We Offer:
Career Development: Personalized support throughout your career journey, including a buddy program for the first six months. Access to a diverse catalog of training opportunities for both hard and soft skills, private language classes, and unlimited access to e-learning platforms like Udemy.
Collaborative Environment: Join vibrant communities within the organization where you can pursue your interests and collaborate with like-minded professionals on innovative projects. Opportunities for international collaboration and the chance to work worldwide.
Competitive Package: Enjoy a competitive salary with a flexible mobility package that includes options for electric cars, bikes, and housing assistance. Become part of a team that embraces the latest technologies in a dynamic, innovative work environment.
Are you ready to take the next step in your career and contribute to transforming the healthcare landscape? Don't hesitate to apply today!
Career Development: Personalized support throughout your career journey, including a buddy program for the first six months. Access to a diverse catalog of training opportunities for both hard and soft skills, private language classes, and unlimited access to e-learning platforms like Udemy.
Collaborative Environment: Join vibrant communities within the organization where you can pursue your interests and collaborate with like-minded professionals on innovative projects. Opportunities for international collaboration and the chance to work worldwide.
Competitive Package: Enjoy a competitive salary with a flexible mobility package that includes options for electric cars, bikes, and housing assistance. Become part of a team that embraces the latest technologies in a dynamic, innovative work environment.
Are you ready to take the next step in your career and contribute to transforming the healthcare landscape? Don't hesitate to apply today!
Praktische informatie
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AGO Jobs & HR Zelzate
Grote Markt 79
9060 Zelzate
Tel.: Toon nummer
Email: Toon emailadres
AGO Jobs & HR Zelzate
Grote Markt 79
9060 Zelzate
Tel.: Toon nummer
Email: Toon emailadres
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