Lead CQV Engineer - Utilities for GMP Pharma Projects

CAI; Ireland; Sur place; EUR 90 000 - 130 000; Plein temps

Résumé du poste

CAI is seeking a Lead Commissioning & Qualification Engineer - Utilities to provide technical leadership for CQV activities on critical utility systems supporting GMP manufacturing. You will oversee design review, commissioning planning, field execution and handover for utility generation and distribution across multiple sites in Europe.

The role requires 10+ years in CQV for pharma utilities, hands-on leadership of large-scale GMP capital projects, and willingness to work on-site within Europe,

Qualifications

• 10+ years' experience delivering CQV programmes for pharmaceutical utility systems.
• Strong knowledge of purified water, WFI, clean steam, compressed gases and utility distribution systems.
• Experience leading teams on large-scale GMP capital projects.
• Knowledge of ASTM E2500, ISPE guidance and risk-based CQV methodologies.
• Experience with Kneat and electronic lifecycle documentation systems is advantageous.

Responsabilités

• Lead CQV activities for utility systems including PW, WFI, clean steam and gases.
• Review design packages, engineering deliverables and vendor docs.
• Develop qualification strategies and lifecycle documentation.
• Coordinate FATs, SATs, commissioning and qualification activities.
• Lead turnover inspections and punch list closure programs.
• Support startup and GMP readiness activities.
• Manage utility system schedules across disciplines.
• Interface with engineering, construction, automation, QA and operations.
• Provide technical leadership to CQV engineers and contractors.
• Ensure systems meet quality, safety and compliance.

Connaissances

CQV leadership

Project management

GMP knowledge

Planning & coordination

Team leadership

CQV methodologies

Formation

Degree in Engineering or related field

Outils

Kneat

Electronic lifecycle docs systems

Description du poste

CAI is seeking a Lead Commissioning & Qualification Engineer - Utilities to provide technical leadership for CQV activities on critical utility systems supporting GMP manufacturing. You will oversee design review, commissioning planning, field execution and handover for utility generation and distribution across multiple sites in Europe.

The role requires 10+ years in CQV for pharma utilities, hands-on leadership of large-scale GMP capital projects, and willingness to work on-site within Europe,