CSV Engineer
Lotusworks
Sligo
About Us. A valued and trusted partner to the world’s leading companies. We are committed to service excellence through our talented people who are empowered to be innovative and best in class. Location. In the heart of the Yeats County, You will discover the scenery and beauty of Rosses Point, surf some of the world’s best waves in Mullaghmore, discover Yates’s Isle of Innisfree, visit the home of Countess Markievicz herself, or with everything on your doorstep you could use your home in Sligo as a base to discover the North West. Join us and work with us to deliver the excellent service we are renowned for with our clients. Be part of something great. Your Job Purpose. The CSV Engineer will Develop and execute the qualification of Information Systems software amongst others things. Your Responsibilities: 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. Maintain and support proactive communications regarding automation related activities to ensure conformance and maintain related work schedules. Requirements: 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. Benefits. Life Assurance. Pension Contribution. Training & Educational Assistance (Engineers Ireland CPD Members. Healthcare Contribution. Annual GP Check-Up. Extra Annual Leave. Healthcare Screening. Not ready to apply, or have some questions? Call our Talent Specialist’s on 07191-69783 or Email jobs@lotusworks.com and we will be happy to help! Empowering talent we care about for over 27 years. LotusWorks is an equal opportunity employer. This job originally appeared on RecruitIreland.com.
2853 days ago