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