Validation Engineer

Vor 2 Tagen


Neuenburg, Schweiz TN Switzerland Vollzeit

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Validation Engineer - temporary contract, NeuchâtelClient:

LHH

Location:

Neuchâtel

Job Reference:

b7c2befd9fb2

Job Views:

11

Posted:

21.01.2025

Expiry Date:

07.03.2025

Job Description:

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

Your Responsibilities:
  1. Generation and execution of qualification/validation protocols including the generation, routing and approval of summary documentation.
  2. Work with project teams to develop DOEs and statistically sound tests for appropriate support of results.
  3. Facilitate the execution of Process FMEA and other applicable risk analysis as deemed appropriate.
  4. Complete test method validation, gauges R&R studies and other qualifications or studies to support product testing.
  5. Scheduling coordination, material allocation and alignment of personnel in order to successfully complete validation assignments.
  6. Develop statistically based sampling plans for in-process and final test sequencing.
  7. Ensure that all projects are in compliance with cGMP, cGLP, QSR (including Design Controls), ISO or other applicable requirements.
  8. Support and address comments and suggestions associated with validation and engineering documentation.
  9. Protocol, Deviation, and summary report generation and approval.
  10. Change control, non-conformance and CAPA support.
  11. Participate in FDA inspections, ISO certifications, surveillance audits and customer audits.
Your Profile:
  1. Bachelors Degree in Engineering (Biomedical, mechanical, chemical, or electrical) or Science (Biology, Chemistry).
  2. 2 to 5 years of experience in a Validation or Quality Assurance role for a medical device or pharmaceutical environment.
  3. Demonstrates excellent organizational and communication skills.
  4. Experience with qualifying medical device manufacturing equipment.
  5. Excellent technical writing skills with a thorough understanding of good documentation practice.
  6. Competent in tracking and updating schedules to provide upper management visibility of milestones and achievements.
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