Software Validation Engineer
CSV (Computer Systems Validation) Engineer. PE Global requires a CSV (Computer Systems Validation) Engineer for one of our client sites in Limerick, this position will be for 12 months initially. Summary: 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: Generation, execution, review & approval of IOQ protocols and associated validation documents and CSV assessments e.g. Part11 Assessments, etc. related to IT Infrastructure systems and related IT Applications and system components. 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. Analyzes 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 computerized 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. Please send in your Cv for the attention of Robert Carroll or contact 0214520311 for more information. Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert. This job originally appeared on RecruitIreland.com.
9 days ago