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Computer Systems Validation Engineer

Limerick, Ireland
Role Type
Hannah Doyle
+353 86 107 0950
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Computer Systems Validation Engineer

Department – QA

This position uses policies and procedures to validate/qualify computer systems, including process automation systems, IS applications/infrastructure, and enterprise systems. Plans, coordinates, and participates in a compliant validation process for quality information technology and automation systems which require formal validation documentation under appropriate regulatory requirements and company manufacturing standards.

Essential Duties and Responsibilities include, but are not limited to, the following:

▪ Prepares/reviews validation documentation related to projects/change controls.

▪ Manages change controls and other compliance related tasks e.g. non-conformances.

▪ Participates in the review of current and future CSV procedures and polices

▪ Analyses the results of testing and determines the acceptability of results against predetermined criteria.

▪ Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.

▪ Identifies current and anticipated requirements for compliant computerised operations and suggests methods for the identification, implementation, and maintenance of the procedures, actions, and documentation necessary to ensure compliance within the operation.

▪ Coordinates with other departments or outside contractors/vendors to complete validation tasks.

▪ Participates in regulatory audits and communicates company’s computer validation policies.

▪ Assesses company’s computer systems and identifies any potential Part 11 or Annex 11 gaps.

▪ Manages projects and prepares status reports using Microsoft project and other communication tools.

Education and Experience:

▪ Requires BS/BA in Engineering, Chemistry, or Life Sciences with 5+ years of related experience within the fields of Automation and Computer systems and IT Infrastructure Qualification/validation; will substitute relevant experience for education.

▪ Experience in a GMP environment essential.

▪ Biologics experience highly desirable

Our Vision: To be recognised as the best STEM Contracting & Permanent Recruitment company and the Employer of Choice for top performing Recruiters.

For further information on this role please contact Hannah Doyle on 086 107 0950 Engineering@hero.ieCheck out all our open jobs on our HERO Recruitment website –

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review you data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

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