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Process SME

  1. England, North West
Manchester
  1. Contract
Competitive
  1. Life Sciences
36219
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Process SME - Life Sciences - 12-month contract - Manchester

How would you like the opportunity to work with in one of the largest biopharmaceutical projects in the world? If yes, then this is the assignment for you!

Our client is currently seeking the skills of a Process SME to join their team. Our client develops and delivers life changing medicines to millions of people globally and as part of their growth. With their Drug Substance (DS) manufacturing network growing rapidly, they are committed to growing their portfolio of commercial biologics products supplied worldwide – and this is your opportunity to be involved!


Experience: 
  • Understand business objectives, project scope, schedule, and critical success factors 
  • Understand and engage project stakeholders relevant to SME role  
  • Ensure requirements are appropriately documented and agreed with project stakeholders 
  • All GMP URS should be documented and agreed with project stakeholders in basic design 
  • Work collaboratively with project stakeholders  
  • Note: this includes collaboration between other packages and disciplines 
  • Ensure requirements are understood and included in the scope of works of designer  
  • Proactive engagement with designer to ensure design is being developed in line with requirements 
  • Support work package owners in understanding requirements and design basis 
  • Consulted on work package breakdown and scope of works 
  • Attendance to project meeting, design meetings, SME meetings, and project tier meetings, as agreed with PTM. 
  • Raise issues and escalate through agreed project processes  
  • Input into project risk register and project/work package cost/schedule reviews 
  • Responsible for design assurance reviews for assigned technical packages 
  • Consulted on C&Q plan  
  • Input into SHE risk assessments  
  • Reporting of progress, issues, and escalations to ETS tier process 
  • Review design deliverables to validate that they meet requirements 
  • Prepare for and participate in PDRI 
  • Support PTM in preparation for Engineering Council  
  • Prepare requirements for Detailed Design  

Skills/requirements: 
  • Bio Process background
  • Design experience
  • Vendor / Stakeholder management
  • Must be self-sufficient and able to operate independently.
  • Strong understanding of automation team interactions and systems integration.

Interested in this role? Apply today! 

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