A Global API Manufacturer, based in Dublin are searching for a CQV 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 CQV Engineer will be required to complete all Commissioning, Qualification and Validation (CQV) activities on site, along with equipment re-qualification requirements.
The Engineer will also provide CQV support to locally managed capital projects that are executed on site.
Responsibilities and experience:
- Support the commissioning, qualification and validation of all process equipment, facilities and utilities on site.
- Support the management of ongoing equipment re-qualification requirements.
- Work cross functionally to develop and deliver annual equipment 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.
- Knowledge of validation practices and regulatory guidelines for a pharmaceutical facility.
- Experience with regulatory audits, in particular representing equipment qualification type issues.
- Experience of writing validation plans, requirements gathering, design documentation, system configuration, system testing and troubleshooting
- Experience in writing Validation Master Plans.
- Knowledge of 21CFR Part 11 requirements, ER/ES and data integrity guidelines
- Knowledge of working in any of the following would be an advantage; Active Pharmaceutical Ingredient manufacturing, Drug Product or Secondary Packaging.
If this seems like something you would be interested in please apply and i will be in touch at my earliest convenience.
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta Consultancy Services does not sponsor Visa applications.
CSV Engineer – Permanent – Dublin – Pharmaceutical A Global API Manufacturer, based in Dublin are searching for a CSV Engineer to join their existing manufacturing team on a permanent
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