About Your New Employer:
The Computer Systems Validation team is responsible for Computer System Validation of PC Controlled Instruments in the Quality Control Laboratories and production facilities of a large multi-national Biotech manufacturing facility in Cork. We are seeking an experienced and enthusiastic Computer System Validation Engineer to join our growing CSV team on a long-term contract basis.
About Your New Job:
- Manage Computer System Validation projects from software install to business release
- Generate computer system validation documentation in accordance with site procedures and GMP guidelines
- Liaise with service providers to determine successful installation of instrument software and ensure correct configuration
- Execute test scripts, analyze test results and determine the acceptability of results against pre-determined criteria
- Work with the business to identify and implement procedural controls to mitigate issues found during testing
- Initiate and implement Change Control activities in accordance with Quality Standards and Practices
- Determine solutions or recommendations for changes and/or improvements
- Follow all relevant Environmental, Health and Safety procedures and assist in incident investigations as required
What Skills You Need
- Minimum 3-5 years’ experience validating IT applications e.g. requirements gathering, design documentation, test case development, system & acceptance testing
- IT qualification would be an advantage but not required
- Experience of server and workstation platforms and working in a Win 10 environment
- Experience of SQL databases is an advantage
- Experience of analyzing and challenging s/w to identify gaps.
- 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.
What’s on Offer
- Permanent position
- Excellent base salary
Given the current climate, Interviews will be conducted remotely via MS Teams.
For a confidential discussion on this or any other current job opportunity please contact Sylvia Heldut on 087 709 43 55 / sheldut at sigmar.ie
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