Project Engineer

QCS Staffing Ltd; Leinster; On-site; EUR 52,000 - 78,000; Full time

Job summary

QCS Staffing Ltd. is assisting a global life sciences client in Dublin to appoint a Project Engineer for an initial 9-month contract. The role drives commissioning, qualification and project Change Control within a GMP/regulatory environment.

You will manage URS, FAT, DQ and related testing activities, support supplier-site testing, and coordinate safety, GMP and environmental regulatory requirements across projects in Ireland.

Qualifications

• Extensive experience in Engineering or Commissioning and Qualification Management.
• Technical qualification at third level or equivalent in Engineering.
• Extensive knowledge and demonstrated experience managing Commissioning activities.
• Qualification for Pharmaceutical / Biotechnology projects preferred.
• Knowledge of safety, GMP and environmental regulatory requirements.

Responsibilities

• Prepare User Requirement Specifications (URS) and test strategies.
• Plan and execute testing approaches, including Single Test Approach and OneCQV.
• Execute Design Qualification (DQ).
• Perform component-level impact assessments.
• Manage Project Change Control processes.
• Coordinate Factory Acceptance Testing (FAT) and supplier-site testing activities.

Skills

Engineering management

Commissioning management

Qualification management

Pharma/biotech projects

Safety/GMP/regulatory knowledge

Education

Engineering degree (third level)

Job description

Project Engineer – Ireland – Initial 9-Month Contract – Life Sciences
Our client is a global leader in pharmaceutical innovation, specializing in the development and manufacture of cutting-edge drugs. As they continue to grow, they’re seeking an experienced Project Engineer to support their dynamic team and drive forward groundbreaking projects in Dublin.
What You’ll Deliver

• User Requirement Specifications (URS)
• Test planning and test strategies, including Single Test Approach and OneCQV (combined equipment and automation testing)
• Design Qualification (DQ)
• Component Level Impact Assessments
• Project Change Control
• Factory Acceptance Testing (FAT), including support and participation in supplier-site testing activities

What you’ll need:

• Extensive experience in Engineering or Commissioning and Qualification Management
• Technical qualification at third level or equivalent in Engineering.
• Extensive knowledge and demonstrated experience managing Commissioning activities
• Qualification for Pharmaceutical / Biotechnology projects preferred
• Knowledge of safety, GMP and environmental regulatory requirements.