We are looking for a Computer System Validation Engineers (CSV) to be part of a highly qualified international team dedicated to building neuroelectronic interfaces to cure brain disorders.
Fluent English is MANDATORY;
Todos los posibles candidatos deben leer con atención los siguientes detalles de este trabajo antes de presentar una candidatura.
in fact, Spanish is notrequired.
The work is 100% remote, based anywhere in Spain.
Responsibilities:
* Assessment of new systems for compliance, conducting periodic reviews and reporting on current systems.
* Generation of Validation Strategies and Validation Master Plans.
* Creation of User, Functional and Design Specifications, Test Plans and Test Case, approval of project deliverables.
* Conducting Design Reviews and Design Qualification activities
* Assisting in the development and execution of Test Protocols including FAT & SAT, IQ, OQ, PQ etc.
Technical Requirements:
* Knowledge of GAMP 5 and 21 CFR Part 11 and European regulations associated with the medical device industry BS EN ISO 13485: 2003 & cGMP
* Knowledge in all areas of the systems development life-cycle including planning, specification, design, test and implementation
* Desirable: knowledge of Salesforce.
Conditions:
* Permanent contract with Sandav.
* Salary based on experience.
* Long-term projects.
* 100% Remote work.
* Location: Spain.
* Schedule: Mon-Fri, 9:00 AM to 6:00 PM.
---
About Sandav:
At Sandav, we are a team of about 200 people located in Spain. We work with the leading companies at a national level, assisting them with everything related to Information Technology. xohynlm We provide services ranging from outsourcing, consulting, and technical assistance to recruitment, training, and software development and maintenance.