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CQV Engineer (Equipment), Sligo



Sligo, Ireland 

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Job Description:

The Opportunity

Team Horizon have an opportunity for a CQV Engineer (fill / finish facility). The successful candidate is required to support the qualification of primary / secondary equipment (through to SAT / post SAT support) for equipment including filling / isolator system, autoclaves and clean utilities.

The Role

  • Client-side lead to work with equipment vendors to support the CQV lifecycle activities as part of a new facility start-up project.
  • Responsible for developing and executing commissioning and qualification documentation for new systems and equipment. This will include supporting the complete CQV lifecycle; Writing URS documents, review / approval of Design Specifications, input into the control strategy, development and execution of the test matrix (leveraged) to support offsite / onsite execution (as per ASTM E2500).
  • Experience of working with equipment vendors to develop and execute the CQV lifecycle.
  • Knowledge of utilising a ‘best practise’ methodology to help deliver a science and risk-based approach to CQV for a green field / brown field project start-up

The Person

  • Bachelor’s Degree in engineering or scientific discipline preferred. Associate’s degree or certificate in biotechnology (minimum) required.
  • Direct experience performing validation studies in cGMP biopharmaceutical or aseptic filling environment is required. Knowledge of aseptic processing and liquid filling operations preferred.
  • Must be able to analyse data using basic statistical methods.

Employment Type:

Full time
Company Info
Team Horizon
1 Cedar Crescent, Cedar Park, Westport, Co. Mayo
Westport, Ireland
Phone: +353 98 50600
Web Site: http://www.teamhorizon.ie
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