Our client, a global leader in the biopharma sector, is seeking a Project Engineer Consultant to support a major CAPEX project. This role will focus on the delivery of new process systems, ensuring design, installation, and commissioning meet the highest operational and regulatory standards.
Essential Duties and Responsibilities
* Generation User Requirement Specification (URS) for assigned systems.
* Reviews and approves Basis of Design (BOD) and detail design of assigned systems, including P&IDs, etc.
* Ensures procurement packages (bill of materials (BOM), datasheets, cutsheets, etc.) meet the company's equipment specifications.
* Tracks HAZOP action items and ensures action items are incorporated into system design.
* Attends 30%, 60% and 90% model reviews ensuring systems meet operational, safety and ergonomic requirements.
* Reviews and approves system lifecycle documentation (FS, SDS, IO lists, etc.) and ensures they meet company requirements.
* Attends factory acceptance test (FAT) of associated equipment if required.
* Attends automation software bench FAT if required.
* Supervises and executes Site Acceptance Testing (SAT) and commissioning activities.
* Generates FAT, SAT and commissioning protocols for assigned equipment and ensures protocols meet company specifications.
* Ensures Vendor Document Requirements (VDR) meet company requirements.
* Builds Preventative Maintenance (PM) tasks and spare parts lists on Regeneron Computerised
* Maintenance Management System (CMMS)
Education and Experience
* Requires BS/BEng in Chemical, Process or Mechanical engineering with 3 - 5 years related experience. Direct experience with biopharmaceutical process equipment is preferred. May substitute relevant experience for education.
* Experience with design and commissioning within biopharmaceutical sector would be desirable.
* Experience with DeltaV would be desirable.
Skills
* Project Engineering & CAPEX Delivery
* Commissioning & validation expertise
* Regulatory & GMP compliance knowledge
All applicants must be eligible to work in Ireland and hold a valid work visa as no sponsorship available for this position.
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