Computer System Validation Engineer

Sigmar Recruitment

Cork

Are you an experienced and enthusiastic CSV Engineer with experience providing IT systems validation and compliance expertise - looking for a new permanent opportunity with great suite of benefits ? Look no further - please read on!!!             Job Responsibilities. Managing CSV projects from software install to business release. Generating relevant documentation in accordance with site procedures and GMP guidelines. Liaising with service providers to determine successful installation of instrument software and ensuring correct configuration. Executing test scripts, analyzing test results and determining the acceptability of results against pre-determined criteria. Working with the business to identify and implement procedural controls to mitigate issues found during testing. Initiating and implementing Change Control activities in accordance with Quality Standards and Practices.   Job Requirements 3+ years’ experience validating IT applications (requirements gathering, design documentation, test case development, system & acceptance testing. Degree qualified. Strong oral and written communication skills are required, Experience of server and workstation platforms and working in a Win 10 environment. Familiar with Annex 11/21CFR Part 11 requirements, GAMP 5 and data integrity guidelines. Experience of working in a pharmaceutical API manufacturing operation or a regulated environment is desirable. For a confidential discussion on this or any other current job opportunity please contact Marcel Skolimowski on 021 4847 138 / marcel@sigmar.ie.  .

1199 days ago