Validation engineer
Jobdescription
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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