Validation engineer

vor 1 Woche

Le Locle, Schweiz Randstad (Schweiz) AG Vollzeit

We are currently seeking a Validation engineer for one of our clients in Canton of Neuchatel.

If you are looking to work in a dynamic and very friendly working environment then this is for you.

This is an open-ended temporary contract

Please note this vacancy requires fluency in French.

Your responsibilities:

  • Generation and execution of qualification/validation protocols including the generation, routing and approval of summary documentation.

  • Work with project teams to develop validation strategy and statistically sound tests for appropriate support of results.

  • Complete test method validation, gauges R&R studies and other qualifications or studies to support product testing.

  • Scheduling coordination, material allocation and alignment of personnel in order to successfully complete validation assignments.

  • Develop statistically based sampling plans for in-process and final test sequencing.

  • Ensure that all projects are in compliance with cGMP, cGLP, QSR (including Design Controls), ISO or other applicable requirements.

  • Support and address comments and suggestions associated with validation and engineering documentation.

  • Protocol, Deviation, and summary report generation and approval.

  • Change control, non-conformance and CAPA support.

Your profile:

  • Bachelor's Degree in Engineering (Biomedical, mechanical, chemical, or electrical) or Science (Biology, Chemistry).

  • 2 to 5 years of experience in a Validation or Quality Assurance role for a medical device or pharmaceutical environment.

  • Fluency in French and good command of English

  • Demonstrates excellent organizational and communication skills.

  • Experience with qualifying medical devices, manufacturing equipment or external components.

  • Excellent technical writing skills with a thorough understanding of good documentation practice.

  • Competent in tracking and updating schedules to provide upper management visibility of milestones and achievements.

  • Use of Microsoft office tools

  • Knowledges of statistical techniques


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