Validation engineer

We are currently seeking a Validation engineer for one of our clients in 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

• Knowledges of statistical techniques