Description
Critères de l'offre
* Métiers :
* Validation Engineer
* Expérience min :
* 1 à 5 ans
* Diplômes :
* No Diploma
* Compétences :
* English
* French
* Lieux :
* Neuchâtel
* Conditions :
* Temporary work
* Permanent contract
* Full Time
Critères de l'offre
* Métiers :
* Validation Engineer
* Expérience min :
* 1 à 5 ans
* Diplômes :
* No Diploma
* Compétences :
* English
* French
* Lieux :
* Neuchâtel
* Conditions :
* Temporary work
* Permanent contract
* Full Time
## L'entreprise : LHH ##
**The Adecco Group Switzerland**
Plus d'infos sur LHH
## Description du poste ##
For one of our clients in Life Sciences based in Le Locle, we are looking for a Validation Engineer for an open-end temporary contract.
Your responsibilities:
* Generation and execution of qualification/validation protocols including the generation, routing and approval of summary documentation
* Work with project teams to develop DOEs and statistically sound tests for appropriate support of results.
* Facilitate the execution of Process FMEA and other applicable risk analysis as deemed appropriate.
* 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
* Participate in FDA inspections, ISO certifications, surveillance audits and customer audits
Your profile:
* Bachelors Degree in Engineering (Medical Device, biomedical, mechanical or chemical) or Science (Biology, Chemistry)
* 2 to 5 years of experience in a Validation or Quality Assurance role for a medical device or pharmaceutical company
* Fluent in French and in English
* Demonstrates excellent organizational and communication skills
* Experience with qualifying medical device manufacturing equipment
* 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 Agile, Oracle, Minitab is a plus
* Use of Microsoft office tools
* Strong knowledge of statistical technics
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