Our Partner in Tipperary area develops and supplies the active ingredients and final formulated product for a range of innovative medicines at its manufacturing and R&D facilities. The plant, which has been operating in Tipperary for over 40 years, exports to over 25 countries around the world with primary markets being Europe, USA and Japan. They are searching for a CSV Engineer to work an 11 month contract, managing automation projects on site.
Essential Duties and Responsibilities for this CSV Engineer role include, but are not limited to, the following:
- Successful candidate will be capable of acting as the CSV SME for the project team and providing a standardised CSV approach across capital projects, as defined by the CSV lead.
- Develop and maintain Qualification Plans and Test Plans, aligned with the overall project C&Q plan and with the leveraging strategy
- Develop templates for all SDLC deliverables, compliant with company standards, to ensure consistent implementation of the validation strategy.
- Expert knowledge of GAMP5.
- At least 5 years experience in a similar CSV role in pharma.
- Strong experience in one or all the following systems: DCS (DeltaV), PLC/SCADA systems, MES, OSI PI, Automated Utility Systems, Lab Systems, Building Automation Systems.
- Relevant Computer Science or Engineering degree or equivalent
- Previous experience of API Manufacturing and/or Oral Solid Dose will be advantageous.
If this role is of interest and you have the above experience, please apply now.
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta part of QCS Staffing does not sponsor Visa applications.
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