Senior CSV Engineer 1129
SimoTech require a Senior CSV Engineer for a Pharmaceutical site based in Cork. The ideal candidate will have a minimum of 5 years’ experience in the Pharmaceutical/Life sciences industry, within a projects capacity. This role will involve supporting the in-house Capital Projects Team by ensuring compliance with all regulatory and site standards as well as preparing Validation Reports and other project documentation.
- 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.
- Generation of Automation test protocols on Phases & Sequences, Alarms, Interlocks and Regulatory Control.
- Review and Validation of Automation documents.
- Preparation of Validation reports and Final Test Summary Reports.
- Write, review and upload of Automation Documents into Regulus.
- Writing, Preparation and Compliance reporting of monthly Automation Periodic Review Reports and Impact Assessments.
- Change Control preparation, pre-approval, sanity checks prior to submission.
- Documentation support for departments during Shutdown.
- Work closely with Quality on Departmental projects.
- 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.
- Prior experience of working cross-functionally with several departments is a benefit.
What SimoTech Can Offer
- 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.
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