Beschreibung
REFERENCE: JNJ
ROLE: CSV VALIDATION ENGINEER
SKILLS: CSV, LEGACY REVIEW, GXP
CONTRACT: 6 months Rolling
LOCATION: Grenchen, Switzerland
LANGUAGE: English and German Written and Spoken
Description
CSV VALIDATION ENGINEER
Overall Responsibilities:
Project Quality Support in the CSV Equipment Legacy Review
Project Quality Support in CSV Equipment Remediation Projects
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
Language Skills:
English fluent, German Fluent