CSV Engineer Dublin

Pe Global

Dublin South

CSV ( Computer Systems Validation Engineer. PE Global requires a CSV ( Computer Systems Validation Engineer) on a contract basis for one of our client in Dublin, this position would be for 12 months initially. Candidates must have at least 3 years experience in: - cGMP Regulated Environment. - computer system validation lifecycle. - working knowledge of GAMP software development lifecycle. See full details below: Development of Validation Plans, Installation Qualifications (IQs), Operational Qualifications (OQs) and Summary Reports. • Prepare, execute, document and report validation protocols in line with GMP’s and other regulatory requirements and standards. • Assure that all validation test procedures are in line with current technology, corporate and governmental regulations. • Ensure that the Validation Strategy meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards. • Review and Approve validation protocols and assessments from a quality system documentation perspective. • Liaise with Engineering / Automation and external vendors regarding equipment documentation, HDS, SDS, FDS, User Requirement Specifications (URS’s), and any other associated validation issues. • Participate and communicate as required in project activities. • Develop procedures to manage computerised systems where required. • Develop and present project plans to project management senior staff. Basic Qualifications: • Bachelor of Science/Engineering degree or equivalent. • Knowledge of cGMP’s and other worldwide regulatory requirements. • Problem solving ability and excellent oral and written communications skills. • Understanding of the computer system validation lifecycle. Preferred Qualifications. • Candidates must have demonstrated experience in the delivery and management of IS / Automation systems in addition to a working knowledge of GAMP software development lifecycle, ANSI/ISA-S88 industry standards. • The successful candidate will have a least 3 years experience validating IS Automation systems for manufacturing organizations in the biotechnology or pharmaceutical industries. Please send in your Cv for the attention of Robert Carroll or contact 021 4520311 for more informatioin. 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.

1982 days ago