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Senior Validation Engineer
Entered: 23 Jan 2019
Entered: 23 Jan 2019
An internationally recognised industry leader in Equipment System Integration and System Support is seeking Senior Validation Engineers to join its team. This growing company which has been established for over 10 years 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.
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. There is an attractive salary and benefits package on offer including pension scheme and health insurance. Continued professional development is supported through on-going training and educational courses.
As Validation Engineer you will be working initially on a packaging line validation project.
- 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.
- Bachelor's degree in Science, Engineering, Technology or a related discipline.
- At least 5 years’ experience as a Validation Engineer in the Medical Devices or related Healthcare industry industry
- Packaging experience would be an advantage
- Experience of GxP Computerised Systems
- 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
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.
Apply now by clicking the link below and attaching your CV.
Please note that all enquiries will be dealt with in the strictest confidence