Description
I have an immediate opening for a Validation Engineer with a leading medical device company based in Co Wicklow (Salary €45,000 - €55,000). This is an excellent opportunity to join a growing company in the greater Dublin area on a permanent basis.Working in fast paced environment the successful candidate will report to the Head of Quality and will be responsible for the validation of products and processes within the manufacturing area.
The Validation Engineer will be responsible for the following:
* Generate validation documentation (URS, IQ, OQ, PQ & validation reports) and oversee the execution of protocols for equipment and processes.
* Develop smart, cost effective validation strategies which deliver robust processes whilst maintaining compliance to relevant regulations.
* Ensure consistency on validation/qualification approach across systems and projects.
* Manage the execution of the product/process validation as per the MVP and project plan.
* Work directly with validation representatives from the wider organization to define inputs and requirements to the MVP.
* Ensure all results and data are correct and follow-up on any gaps or discrepancies.
* Liaise with the Engineering function to ensure that equipment validation requirements are maintained from Purchase to Qualification of new technology equipment.
* Provide guidance and direction in the preparation and execution of validation activities, including carrying out training to staff across various functions.
* Maintain validation procedures and templates up to date, focusing on continuous improvement.
Education and Experience:
* A science, engineering or appropriate degree.
* A minimum of three years validation experience in a minimum of two of the following areas ideally in the InVitro Diagnostics or Medical Devices industry:
* Validation of equipment & utilities, including filling & finishing.
* Product performance qualifications.
* Cleaning validation/verification.
* Working knowledge of applicable regulations and guidelines, to include ISO 13485 and QSR/CFR Parts 820, , 21 CFR Part 11, and other relevant guidelines.
* Quality Engineering experience preferable but not essential.
Skills and Behaviours:
The successful applicant will demonstrate the following:
* Excellent communication skills, (both written and verbal), excellent interpersonal and presentation skills.
* Be team focused but with an ability to take the lead and work independently as the need arises.
* Willingness and ability to collaborate with and influence other groups in a positive, team based environment.
* Professional characteristics will include initiative, ingenuity, creativity, resourcefulness, and perseverance.
* Excellent problem solving and troubleshooting skills.
* Pay attention to detail and work with a sense of urgency and have the ability to be impartial and objective.
* Be an active learner and developer of self and others with excellent organisational skills.
* Identify with company's philosophy of being Best in Class.
This is an excellent opportunity to join dynamic company, if you feel you are a good fit please apply directly with an updated CV or contact Derek Sheridan on for further information.