Job Description:
We are currently seeking a Validation engineer for one of our clients in the Canton of Neuchatel.
This is an exciting opportunity to work in a dynamic and very friendly working environment.
Please note that fluency in French is required for this role.
Your Responsibilities:
* Generation and execution of qualification/validation protocols, including the generation, routing, and approval of summary documentation.
* Collaboration with project teams to develop validation strategies and statistically sound tests to support results.
* Completion of test method validation, gauge R&R studies, and other qualifications or studies to support product testing.
* Scheduling coordination, material allocation, and alignment of personnel to successfully complete validation assignments.
* Development of statistically based sampling plans for in-process and final test sequencing.
* Ensuring all projects are in 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.
* 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.
* Demonstrated 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.
* Proficiency in Microsoft Office tools.
* Knowledge of statistical techniques.