SimoTech require a CSV Engineer for a Pharmaceutical site based in Cork. The ideal candidate will have at least 5 years’ experience in the pharmaceutical/life sciences industry project environments.
- Support project activities from a CSV standpoint where required, including but not limited to the preparation of Validation/Qualification plans and strategies, risk assessments, URS, Traceability Matrix, testing, data migration, SOPs and Change Controls.
- Ensure that all industry specific compliance standards are met for computerised and automated systems in line with regulatory requirements including 21 CFR Part 11, Annex 11 and GAMP5.
- Execute test scripts, analyse test results and determine the acceptability of results against pre-determined criteria.
- Determine solutions or recommendations for changes and/or improvements.
- Bachelor’s degree in Engineering, Information Systems or Computer Science.
- Minimum of 5 years CSV experience in Pharmaceuticals or Biotechnology.
- Thorough knowledge of cGMP regulations related to CSV, including 21 CFR Part 11 and EU GMP Annex 11 is required.
- Strong knowledge of computerised system development lifecycle.
- Strong technical writing and communication skills.
- Role provides a high degree of autonomy to allow the successful candidate to reach their full potential.
- Develop new skills and enhance technical ability by working with innovative technologies in a multi-disciplined environment.
- Opportunity to work with large corporate clients on exciting capital projects.
- Flexible working hours and location.
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