CSV Engineer Sligo
Pe Global
Sligo
CSV Engineer Role. PE Global requires a CSV Engineer on a contract basis for one of out clients based in Sligo, the position is for 12 months initially. Development and execution of the qualification of Information Systems software. Development of life cycle documents necessary to address the validation lifecycle for Information Systems software (Planning, Risk, Implementation, and maintenance of the validated state. Ensure that Appropriate Systems are in place to evaluate changes to Validated/Qualified Systems from a Computer Systems/Software Validation perspective to ensure their continued validated/qualified state. Review/Approval of all Computer Systems/Software Validation Documentation. Generate 21 CFR Part11 and Annex 11 Assessments for CSV Project s. Identify GAPs in Project delivery and report to Management. Participate as required in project activities. Report and help resolve issues with respect to CSV Projects. Maintain and support proactive communications regarding automation related activities to ensure conformance and maintain related work schedules. Performs effective document review to support Automation Compliance activities. Other Duties Include. Ensure compliance attributes with respect to 21 CFR Part 11 & Annex 11 compliance, namely. Security. Audit trail. Electronic signature. Time synchronisation. Data integrity. Data migration. Disaster recovery. Qualification, Skills and Experience required. Bachelor’s degree in Computer Science, Computer Engineering, Computer Information Systems, plus 3 years relevant experience. Experience of validating/testing computer systems together with good knowledge of compliance good practise (i.e. GAMP5, 21 CFR Part 11, EU Annex 11 and GxPs). Experience of production and laboratory systems beneficial. Knowledge around MES, SAP, Plant Data Historian, Metrology Instruments and associated software. Experience of IT infrastructure qualification as per regulatory requirements. Experience in the discrete and medical device manufacturing would be a distinct advantage. Please send in your Cv for the attention of Robert Carroll or contact 021 4520311 for more information. This job originally appeared on RecruitIreland.com.
2595 days ago