Validation Engineer
We are seeking a highly skilled Validation Engineer for one of our clients in the Canton of Neuchatel.
This is an opportunity to work in a dynamic and friendly working environment, ideal for those who thrive in collaborative settings.
This is an open-ended temporary contract that requires flexibility and adaptability.
Please note that fluency in French is mandatory for this role.
Key Responsibilities:
1. Develop and execute qualification/validation protocols, including the creation, routing, and approval of summary documentation.
2. Collaborate with project teams to establish a validation strategy and design statistically sound tests to support results.
3. Conduct test method validation, gauge R&R studies, and other qualifications or studies to ensure product testing meets requirements.
4. Coordinate scheduling, allocate materials, and align personnel to successfully complete validation assignments.
5. Create statistically based sampling plans for in-process and final test sequencing.
6. E nsure all projects comply with cGMP, cGLP, QSR (including Design Controls), ISO, or other applicable regulations.
7. Support and address comments and suggestions related to validation and engineering documentation.
8. Generate and approve protocol, deviation, and summary reports.
9. Provide change control, non-conformance, and CAPA support.
Required Profile:
1. Bachelor's Degree in Engineering (Biomedical, Mechanical, Chemical, or Electrical) or Science (Biology, Chemistry).
2. 2-5 years of experience in a Validation or Quality Assurance role for a medical device or pharmaceutical environment.
3. Fluency in French and good command of English.
4. Demonstrates excellent organizational and communication skills.
5. Experience with qualifying medical devices, manufacturing equipment, or external components.
6. Excellent technical writing skills with a thorough understanding of good documentation practice.
7. Competent in tracking and updating schedules to provide upper management visibility of milestones and achievements.