▷ (9/30/2025 A) Process Design SME (API)

1 week ago

Dublin, Ireland Tandem Project Management Ltd. Full time

Overview

Our client is a global pharmaceutical company based in Dublin looking for a Process Design SME to lead the hydrogenation process design through to completion/FAT/installation/start-up and continuous processing train for installation/start-up

Responsibilities

- Understand business objectives, project scope, schedule, and critical success factors.
- Understand and engage project stakeholders relevant to SME role.
- Participate in the capital project team through all phases of the project; these phases include project proposal/charter, conceptual design, detailed design, equipment procurement, construction, installation, start up, commissioning, reviews P&ID’s, validation, and qualification.
- Assess equipment needs and support the generation of equipment URS and specifications for design or purchase.
- Understand 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.
- Consult on work package breakdown and scope of works.
- Participation in project meetings, design meetings, SME meetings, and project tier meetings, as agreed with Technical Manager.
- 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
- Review design deliverables to validate that they meet requirements, including design qualification for GMP packages
- Support the Technical Manager in preparation for Engineering Council
- Prepare requirements for Detailed Design
- Participate in project learning reviews
- Support work package owner in monitoring progress, planning installation/commissioning/qualification activities, and responding to technical queries.
- Prepare and participate in pre-FAT inspections as per C&Q plan
- Prepare and participate in FAT as per C&Q strategy and plan
- Support IQ, OQ, PQ as per C&Q strategy and plan (prepare, review, approve IQP/IPR, OQP, OQR, execute test/witness tests – as per agreed plan)
- Consulted on pre-start up safety review.
- Prepare and participate in construction inspections/walk downs, as required.
- Prepare for and participate in construction acceptance, as required.
- Prepare for and participate in commissioning testing, as required.
- Participate in project learning reviews.

Qualifications & Experience

- Degree in Chemical or Process Engineering
- Project Management Certification an advantage
- Minimum 15 years’ experience on pharmaceutical design projects
- Experience in API a distinct advantage
- Proven project design delivery

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