Summary: 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&IDs, 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 SMEs 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