Validation Engineer

Vor 3 Tagen

Neuchâtel, Schweiz LHH Vollzeit

I am looking for my client, medical device manufacturer based in the canton of Neuchatel, a Validation Engineer for a temporary (long term) 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 (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.

· 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.

#LI-Hybrid

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