Project SME

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Associate Director, Talent Solutions at Tandem Project Management Ltd.

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:

• 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.
• Consult on C&Q plan
• Input into SHE risk assessments and Engineering Compliance tracker
• Review design deliverables to validate that they meet requirements, including design qualification for GMP packages
• 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.

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

Seniority level

• Seniority levelMid-Senior level

Employment type

• Employment typeFull-time

Job function

• Job functionProject Management

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