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, this is an excellent opportunity.
This is an open-ended temporary contract with flexible scheduling.
Please note that fluency in French is required for this position.
Responsibilities:
* Develop and execute qualification/validation protocols, including creating and approving summary documentation.
* Collaborate with project teams to design validation strategies and statistically sound tests for result support.
* Complete test method validation, gauge R&R studies, and other qualifications or studies to support product testing.
* Schedule coordination, material allocation, and personnel alignment for successful validation assignment completion.
* Create statistically based sampling plans for in-process and final test sequencing.
* Ensure compliance with cGMP, cGLP, QSR (including Design Controls), ISO, or other applicable regulations.
* Support and address comments and suggestions related to validation and engineering documentation.
* Generate and approve protocol, deviation, and summary reports.
* Provide change control, non-conformance, and CAPA support.
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.
* Familiarity with Microsoft office tools.
* Knowledge of statistical techniques.