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QC Lab Validation Engineer

  1. NI & Ireland
  1. Contract
24351- ML
  1. Commisions, Qualification and Validation
Date Posted05 Feb 2020
Ireland is a hive of activity at present for the Life Sciences Sector with many Global Pharmaceutical / Biotechnology Organizations investing in new facilities here.

We have an excellent opportunity for a QC Laboratory Validation / CSV Engineer to join a global Biotech company in a state-of-the-art facility initially on a 12-month contract basis.
Who are we looking for?

We are looking for someone with strong expereince in a similar role within the Life Sciences industry. 

You will be experienced at executing validation, data management and data integtrity and will have up to date knowledge of current requlatory requirements for cGMP laboratory equipment validation

As you will act as the CSV SME in the QC Labs, in-depth knowledge of Annex 11 anf CFR Part 11 requirements is a necessity. 

What will your role involve?

Your duties will include, but not be limited to: 
  • Evaluate systems/equipment in accordance with cGMPs, Part 11, and other regulatory requirement
  • Input and define User Requirement specification
  • Working closely with user groups to evaluate, develop, implement and maintain laboratory equipment and systems
  • To work with laboratory personnel to improve processes, streamline workflow, and increase productivity in laboratory operation.
  • Planning, executing and documenting the qualification of new laboratory equipment in a cGMP regulated environment.
  • Developing and maintaining an equipment qualification project plan, as part of the commissioning of new laboratory facilities
  • Writing wraparound IQ/OQ and PQ equipment validation protocols and associated reports.
  • Accompany vendors and ensure that all documentation is completed prior to and during vendor service engineer site visits when performing routine calibration, qualification, requalification and/or preventative maintenance activities in the QC laboratory.
  • Generation and resolution of protocol discrepancies and deviations that arise as required.

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

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