Description
To support a customer project, we are looking for a Validation Engineer (m/f) featuring the below stated skills and experience:Your Tasks:
Project Quality Support in the CSV Equipment Legacy Review
Project Quality Support in CSV Equipment Remediation Projects
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
Your Qualification:
Higher education (Engineer or similar) and background in IT
GAMP5, ISO 13485, ISO 62304, FDA QSR, 21 CFR, Part 820, Part 11
CSV Experience in the area of Medical Devices Manufacturing (not only Pharma)
English & German fluent
Willingness to travel
Language Skills:
German fluent required and proficient Business English required
Location: Freiburg Area
Project time scale: 3 months
Details about this project can be provided. Please don't hesitate to contact us.
If you are interested in this employment opportunity, please send your profile and information about your availability and hourly rate to
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Softpace GmbH