We are currently seeking a Validation Engineer for one of our clients in the 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.
* Knowledge of statistical techniques.
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