Validation Engineer

vor 1 Woche

Le Locle, Neuenburg, Schweiz Randstad Vollzeit
About the Role

We are seeking a highly skilled Validation Engineer to join our team at Randstad. As a key member of our team, you will be responsible for ensuring the quality and compliance of our medical devices and pharmaceutical products.

Key Responsibilities

  • Develop and execute qualification/validation protocols, including the creation and approval of summary documentation.

  • Collaborate with project teams to design and implement validation strategies and statistically sound tests to support product results.

  • Conduct test method validation, gauge R&R studies, and other qualifications or studies to support product testing.

  • Coordinate scheduling, material allocation, and personnel alignment to successfully complete validation assignments.

  • Develop statistically based sampling plans for in-process and final test sequencing.

  • Ensure 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.

  • Generate and approve protocol, deviation, and summary reports.

  • Provide change control, non-conformance, and CAPA support.

Requirements

  • Bachelor's 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.

  • Fluency in French and good command of English.

  • Excellent organizational and communication skills.

  • Experience with qualifying medical devices, manufacturing equipment, or external components.

  • 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.

  • Proficient in Microsoft Office tools.

  • Knowledge of statistical techniques.

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