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Lead Validation Engineer

Expired
  • Salary: Negotiable
  • Job type: Permanent
  • Location: Clare
  • Sector: Engineering
  • Date posted: 10/05/2018
  • Job reference: J385727A

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Our client, a leading re-agents manufacturer in Ireland's south-west, are currently recruiting for a Lead Validation Engineer to join their team on an 18-24 month contract.

As part of a large expansion by the company, the successful candidate for this position will be tasked with leading, implementing and monitoring the validation strategy of the department.


Typical related responsibilities will include but are not limited to the following:

  • Lead a Team of Validation Engineers engaged in the Qualification of a new manufacturing facility and the associated manufacturing equipment and laboratory test equipment. The new facility will be qualified for the manufacture of a new range of diagnostic reagent products.
  • Responsible for the Project Validation Team and for the Writing, Reviewing, Approving and Execution of Validation Protocols and Reports for Equipment, Utilities, Processes, Cleaning, Test Methods, Temperature Mapping and Equipment Software.
  • Ensure compliance to all relevant global and local quality and validation procedures/standards.
  • Prepare plans for Project Validation activities and Monitor progress versus plan using Visual Project Management and Visual Daily Management.
  • Participate in the preparation of User Requirement Specifications to ensure that they comply with Validation and GMP requirements as required
  • Represent Validation at both internal and external audits.
  • Co-ordinate/Supervise Contractor Qualification activities
  • Administer Validation files and ensure that Validation Logging System Database is maintained, tracking Validations and Validation Files and ensuring full record accessibility.


Education/ Experience

  • Third level degree in science or engineering in addition to a minimum of 7 years relevant experience in a GMP/FDA/IMB regulated environment.
  • Experience of formal regulatory audits (e.g. FDA/IMB) and good working knowledge of statistics, desirable.

If you are interested in further information, please contact Dominic on 01 645 5254 or at dominic.callanatexperis.ie

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