SimoTech require a number of experienced CSV Engineers at all levels for an exciting greenfield Biotechnology project based in North Leinster, Ireland. Candidates must have a minimum of 3 years’ experience as a CSV Engineer within Pharmaceutical or Biotechnology project environments.
- Support department activities, 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 the computerised systems are in full compliance with both regulatory requirements and with company policies and procedures.
- Support the resolution of deviations and/or errors and provide quality guidance on GxP regulatory requirements.
- 3rd level Science / Engineering degree required.
- Minimum of 3 years relevant CSV experience in either the Biotech or Pharma industry.
- 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 life cycle.
- Experience of coordination of quality documentation and qualification/validation documentation.
- Strong technical writing and communication skills.
- Excellent stakeholder management.
- 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 projects.
- Flexible working hours and location.
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