Job Description:
We are currently seeking a Validation Engineer for one of our clients in the Canton of Neuchatel.
This is an open-ended temporary contract requiring fluency in French.
Your responsibilities will include:
* Generation and execution of qualification/validation protocols.
* Developing validation strategies and statistically sound tests with project teams.
* Completing test method validation, gauges R&R studies, and other qualifications or studies to support product testing.
* Scheduling coordination, material allocation, and personnel alignment to successfully complete validation assignments.
* Developing statistically based sampling plans for in-process and final test sequencing.
* E nsuring compliance with cGMP, cGLP, QSR (including Design Controls), ISO, or other applicable requirements.
* Supporting and addressing comments and suggestions associated with validation and engineering documentation.
* Generating protocol, deviation, and summary reports, and ensuring approval.
You should have the following profile:
* A 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.
* 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.
* Competence in tracking and updating schedules to provide upper management visibility of milestones and achievements.
* Familiarity with Microsoft Office tools.
* Knowledge of statistical techniques.