Process SME – API

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Process SME – API - Ireland, Dublin - 12 Month Contract

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

Our client is currently seeking the skills of 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

Essential Duties and Responsibilities for this role include, but are not limited to, the following:

• Understand business objectives, project scope, schedule, and critical success factors
• Understand and engage project stakeholders relevant to SME role
• Participate in the APICOM capital project team through all phases of project
• Understand your project remit in terms of scope of work and interfaces with other SME's scope of works.
• Ensure requirements are appropriately documented and agreed with project stakeholders
• All GMP URSs to be documented and agreed with project stakeholders in basic design
• Work collaboratively with project stakeholders, including 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
• Produce agreed project deliverables in accordance with project schedule deadlines
• Support work package owners in understanding requirements and design basis and in planning and delivery of work packages
• Support procurement activities, as required
• Consulted on work package breakdown and scope of works
• Participation in project meetings, 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 and Engineering Compliance tracker
• Reporting of progress, issues, and escalations to ETS tier process
• Review design deliverables to validate that they meet requirements, Including Design Qualification for GMP packages
• Support PTM in preparation for Engineering Council
• Prepare requirements for Detailed Desig
• Participate in project learning reviews
  
  

Desirable Experience:

• Experience with API (Small molecule) & Process design
• Strong stakeholder management.
• Assess equipment needs and support the generation of equipment URS and specifications for design or purchase
• Experience with GMP URSs, which will be agreed with project stakeholders in basic design
• Ensure requirements are understood and included in the scope of works of designer
• Consult in the C&Q plan
  
  

If this role is of interest to you, please apply nowSeniority level

• Seniority levelMid-Senior level

Employment type

• Employment typeContract

Job function

• Job functionManagement and Manufacturing
• IndustriesStaffing and Recruiting

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