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Validation / CSV Engineer

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SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!

The company

Our client is a professional Biotechnology and Medical Devices organization, based in Antwerpen Belgium. is a medical technology company that serves healthcare institutions, life science researchers, clinical laboratories, industry and the general public

Role description

Computerized systems including equipment and installations for :
• Product Handling, Storage, Distribution and Installation
• Inspection, Measuring and Test Equipment

Responsibilities

- Support to the different validation projects, with the Validation Engineer in charge.
- You have to understand the Technical Aspects of the project and to give support in the form of writing/reviewing Validation protocols (IQ/OQ/PQ) en assure that all deliverables are timely delivered.
- Escalation of problems from Validation Engineer to Project Lead
- Working together with different stakeholders as contractors, intern IT, operations, etc
- Responsible for the composing of documentation for the proper processes regarding the ISO13485

Requirements

- The preferred validation model is the V model demonstrated below where CSV means Computerized Systems Validation plus the associated equipment and installations. The V-model is further described in the EDC validation procedure, with more details about each section.
- It’s the purpose to include all the tasks of this V model as of the start of this project, from defining the requirements till the final closure of the project.
- It’s the intention that the documented validation package is part of the scope that must be delivered. The validation needs to be performed by a qualified person in validation activities.
- All validation activities must follow Good Documentation Practices.



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SIRE Life Sciences

Ref. number: 32393
Listed by: SIRE Life Sciences
Listed on: 20-07-2017
Country: Belgium
Region: Anvers
Employment: Freelance
Expertise: 0 - 2 years
Location Type: On location
Language: English
Sector: Medical Devices
Specialisation: Quality

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Contact

THE NETHERLANDS

Spiegelhof
Herengracht 466
1017CA Amsterdam
+31 (0) 20 658 9800

BELGIUM

Science 14 Atrium
14b, Rue de la Science
1040 Bruxelles
+32 (0) 2 588 1277

GERMANY

Fünf Höfe
Theatinerstraße 11
80333 München
+49 (0) 89 3803 8966

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