Validation Engineer

Location Leiden
Discipline: Medical Device
Contact name: Ernest Banor

Contact email: e.banor@panda-int.com
Job ref: 17759
Published: 9 days ago

 

Description:

Validation Engineer Medical Devices

For the Product & Process Development unit within the Surgical Vision in Groningen, we are looking for a validation engineer for various (CSV, Computer System Validation) projects. Term 12 months with the possibility of extension.

Tasks:

  • Drafting and performing validations (in collaboration with Subject Matter Expert (SME)):
    • Drawing up requirement specifications and/or user stories
    • Creating and executing test protocols
    • Written report of protocol execution
    • Where applicable, electronic reporting of protocol export
    • Handling deviations and/or defects and communication with Validation Review Board (VRB)

Profile:

  • Required
    • Experience with GMP (preferably GAMP5), validating (automated) (measurement) equipment and the implementation and documentation thereof
    • Experience with CSV, process and equipment validation
    • Contractor will be supervised and supported by the relevant SMEs, but will have to be able to work independently as much as possible as soon as possible
    • Follow and keep up to date the required training courses in a timely manner. The contractor is assigned an extensive curriculum in the LMS (Learning Management System)
    • Affinity with quality environments (QA)

 

  • Desired/Pre
    • Experience with GAMP5, ISO-13485, CFR21, MDR
    • Experience in medical device industry
    • Languages: good written and oral English (C1), Dutch is an advantage
    • Software: Jira, X-Ray, Minitab

 

Location: Groningen

Start Date: ASAP

 

If you are interested in the above description, apply with your CV

For more information, please contact Ernest Banor on +31 (0)20 20 44 502 or at e.banor@panda-int.com