Our client based in Sligo require a Computer Systems Validation Engineer for a permanent position.
Duties:
• Ensure all Computerized systems are qualified in compliance with Data Integrity policies and regulatory requirements.
• Co-ordination / direction and active participation in the validation of site equipment, facilities, utilities, processes and software in compliance with company policies, FDA, European cGMP and GAMP standards.
• Generation/maintenance of the Validation Master Plans.
• Generation/maintenance of Project Validation Plans.
• Generation of validation plans, protocols and final reports to cGMP standard.
• Review / approval of all protocols and final reports.
• Management of validation change control process.
• Adheres to and supports all EHS standards, procedures and policies

Qualifications and Experience:
• 3rd level qualification in a relevant engineering or scientific discipline.
• Minimum of 2 year’s experience as a Validation Engineer or related role.
• Demonstrated ability to operate as sole contributor with a proactive approach to responsibilities assigned.
• Demonstrated leadership skills in identifying and overcoming challenges.
• Computer System Validation experience highly desirable.

For a confidential discussion and more information on the role, please contact Aideen Cummins on 071-9140252 or email aideen.cummins@collinsmcnicholas.ie
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