Example Job

Harmonics Recruitment; Limerick; On-site; EUR 70,000 - 100,000; Full time

Job summary

Harmonics Recruitment invites applications for a Project Engineer Consultant to support a major CAPEX project in the biopharma sector. The role covers design, installation and commissioning of new process systems to meet regulatory standards, with emphasis on quality, safety and site readiness.

Responsibilities include preparing URS, reviewing BOD & P&IDs, managing BOMs, tracking HAZOP items, participating in model reviews, and delivering FAT/SAT protocols plus commissioning activities.

Qualifications

• BS/BEng in Chemical, Process or Mechanical engineering is required.
• 3–5 years of related experience, biopharma process equipment preferred.
• Experience with design and commissioning in biopharma is desirable.
• DeltaV experience would be desirable.

Responsibilities

• Generate User Requirement Specifications (URS) for assigned systems.
• Review Basis of Design (BOD) and detailed design (P&IDs, etc.).
• Ensure BOMs, datasheets and cutsheets meet equipment specs.
• Track HAZOP actions and incorporate into design.
• Participate in 30%, 60% and 90% model reviews for safe, compliant systems.
• Oversee FAT, SAT and commissioning activities and protocols.
• Ensure VDRs meet company requirements and create PM tasks/CMMS data.

Skills

Project Engineering

CAPEX Delivery

Commissioning & validation

Regulatory & GMP compliance

Education

BS/BEng in Chemical, Process or Mechanical engineering

Job description

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.
• 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