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Validation Engineer: CSV, Legacy, GxP, Medical Devices. German
Eingestellt von Sentinel IT LLP
Gesuchte Skills: Engineer, Support
Projektbeschreibung
Validation Engineer: CSV, Legacy, GxP, Medical Devices. GERMAN
SENIOR CSV VALIDATION ENGINEER
Overall Responsibilities:
* Project Quality Support in the CSV Equipment Legacy Review
* Project Quality Support in CSV Equipment Remediation Projects
* Team Lead of Site CSV Equipment Team
Tasks:
* Cover the part of the GxP-Compliance in the project.
* Creation of the Validation documentation for GxP relevant system elements.
* Know and follow the guidelines regarding the code of conduct, ethics and compliance programs and other relevant regulations
Extended Duties:
* Planning, coordination, execution and reporting of activities related to the project
Requirements:
* Higher education (Engineer or similar) and background in IT
* Experience in similar position or extended experience as executer required.
* Knowledge of national and international regulations and standards
* GAMP5, ISO 13485, ISO 62304, FDA QSR, 21 CFR, Part 820, Part 11
* CSV Experience in the area of Medical Devices Manufacturing
* Team Player
* Excellent Communication skills
* Leadership skills
Language Skills:
*English fluent, German Fluent
SENIOR CSV VALIDATION ENGINEER
Overall Responsibilities:
* Project Quality Support in the CSV Equipment Legacy Review
* Project Quality Support in CSV Equipment Remediation Projects
* Team Lead of Site CSV Equipment Team
Tasks:
* Cover the part of the GxP-Compliance in the project.
* Creation of the Validation documentation for GxP relevant system elements.
* Know and follow the guidelines regarding the code of conduct, ethics and compliance programs and other relevant regulations
Extended Duties:
* Planning, coordination, execution and reporting of activities related to the project
Requirements:
* Higher education (Engineer or similar) and background in IT
* Experience in similar position or extended experience as executer required.
* Knowledge of national and international regulations and standards
* GAMP5, ISO 13485, ISO 62304, FDA QSR, 21 CFR, Part 820, Part 11
* CSV Experience in the area of Medical Devices Manufacturing
* Team Player
* Excellent Communication skills
* Leadership skills
Language Skills:
*English fluent, German Fluent
Projektdetails
Geforderte Qualifikationen
-
Kategorie:
Ingenieurwesen/Technik, Sonstiges