Validation Engineer (m/f) - Baden Württemberg

Beschreibung

For a freelance Project in Baden Württemberg in the field of Medical Devices Industr I am searching for a

Validation Engineer (m/f)

Position: Validation Engineer
Start: asap
Duration: 3 Monate+
Rate: € 70,-
Experience: 3+ years

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 (not only Pharma)
* Team Player
* Excellent Communication skills
* Pragmatist
* motivated, energetic

Language Skills:
* English & German fluent

Qualification

- 21 CFR Part 11 *
- 21 CFR Part 820 *
- CSV *
- FDA QSR *
- FDA regulations *
- GAMP5 *
- GMP (Good manufacturing practice) *
- GxP *
- ISO Regulations *
- Medical devices experiences *

Your swift response is appreciated!

Pleas submitt the latest CV where the above mentioned skills are clearly evident.