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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 level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Project Management
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