Process Sme – Api

2 weeks ago

Dublin, Ireland Quanta Consultancy Services Ltd Full time

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 Design
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 now
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