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Brightpath Recruitment Ltd. logo

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Brightpath Recruitment Ltd.
Office 4, Sligo Airport Business Park,
Strandhill, Co. Sligo.
Tel: 071 9128266
E-mail: jobs@brightpath.ie
Web: www.brightpath.ie

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Validation Engineer

Location: Westmeath
Entered: 17 Oct 2017
Salary:
Duration: Permanent
 
Validation Engineer

An internationally recognised industry leader in Equipment System Integration and System Support is seeking a Validation Engineer to join its team. This is a growing company which has been established for over 10 years and works in the Pharma, Medical Device, Healthcare and Food and Beverage Sectors with clients who require high level expertise in industrial IT integration and regulatory compliance. This is a forward thinking and innovative company who have worked to address a skills shortage in manufacturing by developing a new Masters programme in Mechatronics at the University of Limerick, which is the first of its kind in Europe.


Career Development:

This company offers employees extensive opportunities for professional and personal development and these include:
  • Career growth: Through a clear Career Development Programme for all staff.
  • Technical development: The opportunity to work on highly technical projects with an excellent client base.
  • Comprehensive benefits package: An excellent benefits package tailored to the specific needs of staff.
  • Lifelong learning: Staff are encouraged to avail of additional training & development through in-house training and there is also a support programme available to employees completing additional training or educational courses.
  • Travel opportunities: The diverse range of projects you could work with means there are travel opportunities available for employees not only within Ireland and the UK but internationally.
What’s on offer?

This is a permanent position offering the opportunity to work on client tailored programmes working within the medical devices and healthcare industries. Continued professional development is supported through on-going training and educational courses. It is an excellent opportunity advance your career working on leading technologies and systems.

As Validation Engineer you will be working to ensure conformance to Quality systems, to liaise with various departments, and give guidance, review documentation and ensure the company validation policies & procedures are being adhered to.

Responsibilities:
  • Contributing to the preparation and review of the Validation Master Plan 
  • Managing the preparation, review and issuing of validation protocols and reports 
  • Generating validation documentation including risk assessments, traceability matrices, and validation reports. 
  • Reviewing and approving specifications associated with Equipment, Processes, Products and Computerised Systems. 
  • Reviewing and managing change control forms for Validation/Compliance implications. 
  • Conducting routine Internal Quality Audits of the facility to ensure compliance 
  • Updating existing quality documentation related to validation activities. 
  • Identifying training requirements in support of validation. 
  • Conducting Risk Assessments. 
  • Developing and reviewing software validation plans, test protocols, test data and test reports for embedded medical device. 

Requirements:
  • Bachelor's degree in Science, Engineering, Technology or a related discipline. 
  • At least 2 years of experience working within the medical devices industry or related Healthcare industry would be desirable 
  • Industry knowledge of EU GMP (IMB/FDA), Annex 11 Computerised System Validation, ISO quality requirements.
  • Familiar with the GAMP5 guidelines. 
  • Strong interpersonal skills
  • Open to travel
Apply now by clicking the ink below and attaching your CV.

Please note that all enquiries will be dealt with in the strictest confidence

 

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