CSV Engineer
- Dublin
- Permanent
- Commissioning, Qualification and Validation
This vacancy has now expired
A Global API Manufacturer, based in Dublin are searching for a CSV Engineer to join their existing manufacturing team on a permanent basis.
The well established site is located in a desirable part of Dublin - easily commutable from Dublin city.
The CSV Engineer will complete all Computerised System Validation (CSV) activities on site, along with periodic re-qualification requirements. The Engineer will also provide CSV support to capital projects that are executed on site.
Responsibilities and experience:
- Support the CSV requirements for site production and laboratory systems.
- Support the management of ongoing CSV re-qualification requirements.
- Work cross functionally to develop and deliver the annual CSV re-qualification requirements.
- Provide CAPEX team with adequate validation support at all times.
- Review vendor documents to support commissioning and qualification requirements.
- Completes the development, review and execution of validation plans, URSs/DQ/FATs/SATs/IQ/OQ protocols/reports.
- Ensures validation non-conformances or deviations are minimised during execution of CSV activities. For issues that do arise ensure they are closed out in a timely manner.
- Supervise vendors/ contractors on site as required.
- At least three years validation experience (CSV) within a pharmaceutical setting.
- Knowledge of validation practices and regulatory guidelines for a pharmaceutical facility.
- Experience with regulatory audits, in particular representing computer system type issues.
- Experience of writing validation plans, requirements gathering, design documentation, system configuration, system testing and troubleshooting
- Knowledge of 21CFR Part 11 requirements, ER/ES and data integrity guidelines would be an advantage.
- Knowledge of working in any of; Active Pharmaceutical Ingredient manufacturing, Drug Product or Secondary Packaging would be an advantage.
If this role is of interest to you then please apply!
The candidate must have the rights to work in the location stated in the job advert.
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I have always received a highly professional & personable service from the team at Quanta. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
We have worked together with Quanta for seven years now and have always received a professional service. Quanta’s speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of Quanta’s people and their ability to deliver.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
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