Process Sme – Api

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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