Our client, a medical device company in Clonmel are currently looking to recruit a Validation Engineer to cover a maternity leave contract.
Working within the on-site Laboratory you will support new process/product introductions and process improvement requirements through writing, executing and review of IQ/OQ/PQ protocols to ensure that all relevant equipment is qualified for cGMP use.
Design and develop validation documentation to support new process introduction.
Execute validation studies.
Implement and co-ordinate the change control process while ensuring the timely approval of change documentation.
Conduct data analysis to evaluate process capabilities and make recommendations for process improvements where necessary.
Investigate and trouble-shoot instrumentation issues which occur and determine solutions.
Assist in audit preparation for lab equipment for internal and regulatory audits
Drive continuous improvement in lab operations through labs LBP.
Support the Company Programs and culture
Perform laboratory duties and other required support functions to support department objectives.
Qualifications & Experience:
Degree in a Science / Engineering discipline or equivalent.
A proven track record in development or support of validation programs in areas of equipment and laboratory equipment.
Knowledge of laboratory processes for equipment calibration and validation.
Previous experience in qualification and validation of computerised systems would be a distinct advantage.
Strong analytical and associated problem-solving skills.
Excellent track record in safety compliance.
The successful candidate must demonstrate excellent written and verbal communication skills and have the ability to work in a team based collaborative environment
For further information on this Validation Engineer role in Clonmel please contact Anna Carty on 086 8168298/ email@example.com
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