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QC Lab Validation Engineer

  1. NI & Ireland
Dublin
  1. Contract
Competitive
  1. Commissioning, Qualification and Validation
27817/JS

This vacancy has now expired

QC Lab Validation Engineer – Dublin – 12-Month Contract

As Dublin continues to embed itself as Ireland's Pharmaceutical capital, we are seeking a QC Lab Validation Engineer to become part of a $500 million state of the art bio facility.

Located 15 minutes from Dublin Airport and just a short distance from the lively, vibrant, and cultural Irish capital, this leading biopharmaceutical organisation leads the way with state of the art technology on their one of a kind manufacturing facility. 

Essential Duties and Responsibilities for this QC Lab Validation Engineer role include, but are not limited to, the following:
  • As the QC Lab Validation Engineer you will be responsible for evaluating Systems and/or Equipment in accordance with cGMPs, Part 11 and other Regulatory requirements.
  • The QC Lab Validation Engineer will work closely with user groups to evaluate, develop, implement and maintain Laboratory Equipment and Systems.
  • You will improve processes, streamline work-flow and increase productivity in Laboratory operation and also plan, execute and document the Qualification of new Laboratory Equipment.
  • The QC Lab Validation Engineer will write wraparound IQ/OQ/PQ Equipment Validation Protocols and associated reports.
  • You will accompany vendors and ensure that all documentation is completed prior to and during vendor service engineer site visits when performing routine Calibration, Qualification, Re-qualification and Preventative Maintenance activities in the QC Laboratory.
Desirable Experience:
  • As the QC Lab Validation Engineer you will be qualified to degree level in Software, Engineering, Chemistry or Biological discipline and have a minimum of 3 years’ experience.
  • The QC Lab Validation Engineer will be a Subject Matter expert for Computer Systems Validation.
  • You will have strong experience at executing Validation, Data Management and Data Integrity and an in-depth knowledge of Annex 11 and CFR Part 11.
  • The QC Lab Validation Engineer will have excellent knowledge of Methodology, Instrumentation and Analytical Techniques used for Biopharmaceutical Testing.
If you feel you match all these requirements and this position is of interest, then please apply now and we can discuss further.

The candidate must have the rights to work in the location stated in the job advert.

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