Validation Engineer
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Validation Engineer (m/w) - open end temporary contract, NeuchâtelClient:LHH
Location:Neuchâtel
Job Reference:6189b539974e
Job Views:4
Posted:14.03.2025
Expiry Date:28.04.2025
Job Description:For one of our clients in Life Sciences based in Le Locle, we are looking for a Validation Engineer for an open-end temporary contract.
Your responsibilities:
- Generation and execution of qualification/validation protocols including the generation, routing and approval of summary documentation.
- Work with project teams to develop DOEs and statistically sound tests for appropriate support of results.
- Facilitate the execution of Process FMEA and other applicable risk analysis as deemed appropriate.
- 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.
- Participate in FDA inspections, ISO certifications, surveillance audits and customer audits.
Your profile:
- Bachelors Degree in Engineering (Medical Device, biomedical, mechanical or chemical) or Science (Biology, Chemistry).
- 2 to 5 years of experience in a Validation or Quality Assurance role for a medical device or pharmaceutical company.
- Fluent in French and in English.
- Demonstrates excellent organizational and communication skills.
- Experience with qualifying medical device manufacturing equipment.
- 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 Agile, Oracle, Minitab is a plus.
- Use of Microsoft office tools.
- Strong knowledge of statistical techniques.
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