Team Horizon are recruiting a CSV Engineer for a 12 Month Contract role based on our clients Medical Device manufacturing facility in Co Sligo. This job creates a fantastic opportunity for a CSV Engineer to enhance their portfolio with a global leading medical device manufacturer.
Skills: Product Development,Pharmaceutical Industry,Medical devices,GAMP5,MES, SAP,CSV Engineer, EU Annex 11 and GxPs,CFR ,GPM ,MERP Systems
Sectors: Engineering / Utilities
Questions: Have you a bachelors degree or third level equivalent in an engineering or science discipline?,Have you experience in leading projects?
Text title: The Person
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.Ability to design, lead and schedule validation activities.Experience working knowledge of GMP controlled manufacturing operations.