Validation engineer

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

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

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

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

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

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

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p>Support and address comments and suggestions associated with validation and engineering documentation.

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p>Protocol, Deviation, and summary report generation and approval.

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p>Change control, non-conformance and CAPA support. 

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p>Your profile:

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

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

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p>Fluency in French and good command of English

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p>Demonstrates excellent organizational and communication skills.

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

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

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

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p>Use of Microsoft office tools

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p>Knowledges of statistical techniques