Reference Code
DU1888

We are seeking an experienced Subject Matter Expert in the area of Aseptic Fill Finish to join the global technology team.

The role is to work as a Subject Matter Expert providing technical leadership on aseptic fill finish projects.  As a part of the global technology team the person employed can be located in one of the PM Group offices in US, Europe or Asia, or possibly can work remotely from their home location with travel to project meetings/workshops as required.

 

Responsibilities

  • Manage and produce/check the project early stage process deliverables required for a aseptic fill finish facility which includes scoping and philosophy documents, production throughput analysis and it’s translation to line speed/capacity, process flow diagrams, equipment requirements, P&ID’s and layout philosophies
  • With excellent presentation skills it will be required to interface with clients and facilitate workshops
  • Technically assist project teams particularly in the early project phases such as Site Master Planning, Feasibility and Concept Studies, as well as Basic Design
  • Engage with an existing global network of Subject Matter Experts and assist in the training and mentoring of next generation of Subject Matter Experts in the company
  • Have the ability to distil down problems to their essence, demonstrate problem solving skills and have a talent to innovate

 

Qualifications & Requirements

  • 20 years+ experience in design and/or operations and/or process development of aseptic fill finish systems and facilities is essential
  • A history of wider industry engagement with institutions such as the ISPE and an awareness of key industry technology initiatives and direction would be ideal
  • Excellent knowledge of vial filling, syringe filling, lyophilisation and other fill finish technologies
  • Familiar with equipment options available and the selection criteria as to when such options should be chosen
  • A good understanding of the principles of layout of a facility to accommodate an aseptic fill finish facility, and how to achieve the operation with the HVAC grades associated with the required process steps
  • A good understanding of isolators and RABs and the associated decontamination systems
  • Good appreciation of GMP Regulatory framework for implementation of aseptic fill finish systems

Please Note

All CV’s are treated in the strictest confidence.
Recruitment agencies need not apply.

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Aseptic Fill Finish Subject Matter Expert DU1888 - DU1888

Dublin, Ireland

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