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