Job Title: Validation Engineer
We are seeking a skilled Validation Engineer to work in a dynamic and friendly environment. This is an open-ended temporary contract.
Please note that fluency in French is required.
* Develop and execute qualification/validation protocols, including generating, routing, and approving summary documentation.
* Collaborate with project teams to create validation strategies and statistically sound tests to support results.
* Conduct test method validation, gauges R&R studies, and other qualifications or studies to support product testing.
* Schedule coordination, material allocation, and personnel alignment to complete validation assignments.
* Develop statistically based sampling plans for in-process and final test sequencing.
* E nsure compliance with cGMP, cGLP, QSR (including Design Controls), ISO, or other applicable requirements.
* 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.
Your Profile:
* Bachelor's Degree in Engineering (Biomedical, mechanical, chemical, or electrical) or Science (Biology, Chemistry).
* 2-5 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.
* Competent in tracking and updating schedules to provide upper management visibility of milestones and achievements.
* Familiarity with Microsoft Office tools and statistical techniques.