CQV Engineer

CQV Engineer – Permanent – Dublin – Pharmaceutical

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.

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