Junior Verification Engineer

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Job Description

Junior Verification Engineer 

Pfizer Grange Castle, Dublin 

The role is to support the validation of the project equipment adopting the Verification approach. The role will include:

  • Steam in Place (SIP) Verification/Cycle Development and PQ of Bioreactor and Vessel Skids/pipework.
  • Commissioning and qualifying new controlled environmental devices (CEDs) such as freezers, fridges and incubators;
  • Load configuration / Coverage Testing Parts Washer loads;
  • Cycle development and PQ for new Autoclave loads; and
  • General equipment verification/CQV activities as required.

This role will include testing the Installation Verification (IV) and Functional Verification (FV) (or CQV equivalent) on the units, along with temperature mapping (PQ) to ensure that the units meet user’s requirements.

The person will ensure that all newly installed units are commissioned or qualified; operate according to Pfizer GEP/GMP standards, procedures, specifications and safety requirements; are fit for use over the agreed life time of the unit; and are brought into operation with minimum cost and impact to the site business units.

Responsibilities:

Specific activities and responsibilities will include:

  • Completing the Installation Verification (IV), Functional Verification (FV) (or CQV equivalents) and Performance Qualification (PQ) of CEDs, Autoclave load cycle development & PQ and SIP PQ planning and execution.
  • Load configuration / Coverage Testing Parts Washer loads;
  • Programming and installation of LIVES temperature and relative humidity loggers & thermocouples for mapping of units.
  • Writing, review and approving protocols / test scripts.
  • Completion of test protocols, data analysis and generation of conclusions.
  • Generating and managing events / deviations / engineering change controls.
  • Execution Verification / CQV works utilising the necessary Pfizer safe systems of work
  • Ensuring all Pfizer and engineering policies and procedures are adhered as applicable
  • Scheduling and coordinating work to tight deadlines.
  • Providing progress updates for systems/equipment and maintaining project progress to agreed timelines.
  • Interface with in-house customers, project groups and QA as required in the delivery of the project.

Qualifications:

  • Minimum qualification B.Sc./B.Eng or M.Sc./M.Eng Degree in Chemical, Mechanical or Building Services Engineering, Chemistry, Instrumentation or Biological Science, or equivalent.
  • At least 3 years of experience qualifying GMP systems.
  • Experience of temperature mapping and of using mapping equipment and Biological Indicators (BIs) to qualify Vessels & Pipework, reach in and walk in fridges, freezers, incubators, and/or Autoclaves
  • Experience of validation processes and regulatory requirements.
  • Experience of authoring test scripts / protocols, test data compilation with summary reports and statistical analysis of same.
  • Excellent documentation practices.
  • Experience and understanding of the importance of following site quality, validation and engineering procedures.
  • Aptitude for technical learning, technical writing and problem solving individually and as part of a team.
  • Ability and experience of managing, prioritizing and delivering assigned work to meet project, customer and/or departmental requirements.
Apply via LinkedIn

Shyni Fernandez

Talent Partner +353 1 614 6053 shyni.fernandez@cpl.ie
  • Salary:Negotiable
  • Location:Grange Castle
  • Type:Contract
  • Category:Engineering
  • Ref.no:JO-1904-428018_42