Validation engineer

vor 5 Monaten

Le Locle, Schweiz Randstad Vollzeit
Jobdescription

We are currently seeking a Validation engineer forone of our clients in Canton of Neuchatel.

If youare looking to work in a dynamic and very friendly workingenvironment then this is for you.

This is anopen-ended temporary contract

Please note thisvacancy requires fluency in French.

 

Yourresponsibilities:

  • Generationand execution of qualification/validation protocols including thegeneration, routing and approval of summarydocumentation.

  • Work withproject teams to develop validation strategy and statisticallysound tests for appropriate support ofresults.

  • Complete testmethod validation, gauges R&R studies and other qualificationsor studies to support producttesting.

  • Schedulingcoordination, material allocation and alignment of personnel inorder to successfully complete validationassignments.

  • Developstatistically based sampling plans for in-process and final testsequencing.

  • Ensure that allprojects are in compliance with cGMP, cGLP, QSR (including DesignControls), ISO or other applicablerequirements.

  • Support andaddress comments and suggestions associated with validation andengineeringdocumentation.

  • Protocol,Deviation, and summary report generation andapproval.

  • Change control,non-conformance and CAPAsupport.

 

Yourprofile:

  • Bachelor's Degree inEngineering (Biomedical, mechanical, chemical, or electrical) orScience (Biology,Chemistry).

  • 2 to 5 years ofexperience in a Validation or Quality Assurance role for a medicaldevice or pharmaceuticalenvironment.

  • Fluency inFrench and good command ofEnglish

  • Demonstratesexcellent organizational and communicationskills.

  • Experience withqualifying medical devices, manufacturing equipment or externalcomponents.

  • Excellenttechnical writing skills with a thorough understanding of gooddocumentationpractice.

  • Competent intracking and updating schedules to provide upper managementvisibility of milestones andachievements.

  • Use ofMicrosoft officetools

  • Knowledges ofstatistical techniques


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