Validation Engineer, CONTRACT, Medical Device, Switzerland

Vor Ort
4 months
Michael Bailey Associates - UK Contracts
flag_no Schweiz

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For our large multinational client in Switzerland, we are currently searching for a Validation Engineer to provide support for: Validation activities associated with Functional and Physical test methods ensuring that all compliance issues and requirements of Test Method Validation Policies and Procedures are addressed.

The ideal validation engineer will have:

  • A degree in an appropriate discipline (eg Engineering, life-science, natural sciences) with a broad technical/educational skill base and substantial related experience
  • Minimum of 2 - 5 years working in a regulated industry including 2 of which has been spent carrying out validations.
  • Expert knowledge of Functional and Physical Test Method Validation.
  • Manufacturing and Medical Device production process knowledge.
  • In depth knowledge of 21 CFR 820, 21 CFR 11 and European regulations associated with the medical device industry (ISO 13485, ISO 9001 and technical norms related to validation), knowledge of GHTF.
  • High understanding of GMP, GDP, GXP, Compliance, Validation Practices including the system development life cycle and Regulatory expectations.
  • Working experience of validation and test method validations for use in a FDA regulated environment.
  • Knowledge of process statistics (desirable Six Sigma Green Belt or higher certification)
  • Knowledge of MSA for mechanical industries, metrology and calibration for highly regulated environments

We welcome applications of consultants' who match most of the above requirements and are available on a short notice. There is a competitive Hourly rate available for the contract; alternative market rates are also welcome. Please note there is a job description available on request.

We hope the role will be of interest to you and understand that further information may be required before making an application to the end client, please feel free to send either your full name, contact details or a complete CV via this website and I will endeavour to get back to you with further information on the role and answer any questions you may have.

Kind regards,

Neha Sharma

MBA Michael Bailey Associates

Job Code: 108246

Keywords: Validation engineer, Physical test methods, Test Method Validation, 21 CFR 11, regulations, Medical devices, GMP, GDP, GXP, Compliance, Validation Practices, risk Management, ISO 13485, ISO 9001, FDA, process statistics, MSA, Six Sigma Green Belt, Protocols, documentation, GHTF, metrology, calibration, engineering, regulatory affairs, German, English, Quality, QA, Switzerland, Basel

Michael Bailey International is acting as an Employment Business in relation to this vacancy.