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CSV Engineer

  1. Dublin
  1. Permanent
Dependent on Experience
AB 25370
  1. Commisions, Qualification and Validation
Date Posted08 Sep 2020
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 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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