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Process Lead

  1. Italy
  1. Contract
Competitive
  1. Life Sciences
12-05-2023
31350
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Process Lead- Life Science- Contract- Milan

Our client, a global pharmaceutical organisation is responsible for developing and manufacturing medicines and vaccines for a wide range of medical disciplines.

With continued organisational growth and a considerable amount of investment across the portfolio and capital programme they are seeking the expertise of Process Lead.
 
Process Lead Responsibilities:
  • Provide management support for a team of client representatives for Process Delivery of the project.
  • Review and approval of A/E firm process engineering design deliverables.
  • Implement Process design quality and design change.
  • Support the Technical Lead as an interface for Technical / Process aspects of the project with EP Services provider during the Engineering phase of the project.
  • Define internal Process Technical expectations to EP Service provider and ensure delivery in line with this expectation, including the application of standards and guidelines.
  • Engage with internal Process End Users and SMEs to define process, product & facility technical aspects for the project in support of successful project delivery.
  • Manage review and approval of PFDs & P&IDs at various revisions.
  • Ensure that EHS&S considerations are appropriately addressed throughout the Engineering phase of the project, including but not limited to HAZOP / SWIFT studies.  Ensure that appropriate attendees from the Process Technical group are represented at all such sessions.
  • With the Project Quality Lead, ensure that the appropriate Quality standards are applied for the project, consistent with best practice and internal Quality Standards and expectations.
  • Lead the Process Technical group as the primary inputs to the Automation aspects of the project, specifically focused upon the Process Automation System (PAS) and Manufacturing Execution System (MES).  This includes review and approval of all Users Requirements Specifications (URS), Functional Design Specifications (FDS) and Detailed Design Specifications (DDS).
  • Escalate issues to the Technical Lead, as required and necessary to avoid impacting upon project KPIs.
About you:
  • Min qualification – BS in Engineering Discipline (or equivalent).
  • Experience of A/E Design Firm project execution
  • Minimum (8 years) pharmaceutical/biopharmaceutical engineering project experience for Lead positions.
  • Previous experience in design of project >$100 MM required
  • Knowledge of and direct operational experience within manufacturing facilities including large molecule, small molecule and sterile injectables.
  • Knowledge and experience of project execution for fully automated facility design
  • Experience of facility design in a 3D Model / BIM environment utilising integrated project delivery
  • Experience of Equipment vendor package management and design coordination
  • Knowledge and experience of commissioning & qualification
  • Strong knowledge of problem solving, root cause analysis, operational excellence techniques.
  • Previous experience as People Manager preferred with knowledge of HR practices
Are you a good fit for a Process Lead? Get in touch with us today.

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

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