*Role     Validation Engineer - Medical Devices*

Duration: 9+ Months

Location:  PA, CO, NY , FL

Skill Tag          Black Box Testing, CSV, ISO 13485

*Overall Responsibilities: *

Project Quality Support in the CSV Equipment Legacy Review

Project Quality Support in CSV Equipment Remediation Projects


v  Cover the part of the GxP-Compliance in the project.

v  Creation of the Validation documentation for GxP relevant system

v  Know and follow the guidelines regarding the code of conduct, ethics and
compliance programs and other relevant regulations

Extended Duties:

v  Planning, coordination, execution and reporting of activities related to
the project Requirements:

v  Higher education (Engineer or similar) and background in IT

v  Experience in similar position or extended experience as executer

v  Knowledge of national and international regulations and standards

v  GAMP5, ISO 13485, ISO 62304, FDA QSR, 21 CFR, Part 820, Part 11

v  CSV Experience in the area of Medical Devices Manufacturing

v  Team Player

v  Excellent Communication skills

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