Validation Engineer

vor 2 Wochen


Neuenburg, Schweiz TN Switzerland Vollzeit

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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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