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 include, but are not limited to, the following: Generation User Requirement Specification (URS) for assigned systems.
Reviews and approves Basis of Design (BOD) and detail design of assigned systems i.
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 Delta V would be desirable All applicants must be eligible to work in Ireland and hold a valid work visa as no sponsorship available for this position.
Skills: Project Engineering & CAPEX Delivery Commissioning & validation expertise Regulatory & GMP compliance knowledge