We are looking for experienced CSV Engineers for existing and new projects in Dublin, Cork and Waterford.
- Support department activities, including but not limited to the preparation of Validation/Qualification plans, 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 Pharma or Biotech 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 in particular qualification/validation documentation.
- Validation experience with ERP, MES, DCS, LIMS, PLC and Quality Systems
- Ability to present validation documentation during the IMB, FDA and Corporate audits
Contact us to discuss this opportunity further.