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Lead C&Q Engineer - Utilities

CAI • Engineering Services • Testing, Inspection & Certification • Bachelor's Degree • 2 days ago
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Salary
≈ $71k – $152k per year (Estimated)
Location
In office (Frankfurt am Main, Ireland)
Seniority
Staff · 10+ years exp
Employment
Contractor

Confirmed on the employer's own hiring board on Oct 23, 2026. First seen by Alion on Oct 21, 2026. CAI scores C on the Alion truth index.

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CAI

CAI is a professional services firm headquartered in Indianapolis, Indiana, providing commissioning, qualification and validation, operational readiness and staff augmentation services to the life sciences and mission critical industries, including pharmaceutical plants and data centers. Established in 1996, it has grown to nearly 800 people working on client projects in North America, Europe, Asia and Australia. It hires commissioning project managers and engineers for data centers, CQV and computer system validation engineers, automation and sterility assurance engineers, quality and regulatory specialists and global finance directors.
caiready.com • HQ: Indianapolis, United States • Testing, Inspection & Certification • Engineering Services • 501-1000 employees • Est. 1996
Backed by JLL Partners

At CAI, we help our clients deliver critical life sciences facilities safely, efficiently and compliantly. We provide technical expertise across commissioning, qualification, validation and operational readiness programmes.

We are seeking an experienced Lead Commissioning & Qualification Engineer - Utilities to support a major European pharmaceutical manufacturing expansion project.

Position Summary

The Lead C&Q Engineer - Utilities will provide technical leadership for commissioning and qualification activities relating to critical utility systems supporting GMP manufacturing operations.

This role will focus on utility generation and distribution systems, leading teams through design review, commissioning planning, field execution, qualification and final handover.

Responsibilities

  • Lead CQV activities for utility systems including purified water, WFI, clean steam, process gases, clean compressed air and supporting utility infrastructure.
  • Review design packages, engineering deliverables and vendor documentation.
  • Develop and approve qualification strategies and CQV lifecycle documentation.
  • Coordinate FATs, SATs, commissioning and qualification activities.
  • Lead construction walkdowns, turnover inspections and punch list closure programmes.
  • Support startup, operational verification and GMP readiness activities.
  • Manage utility system schedules and coordinate execution across multiple disciplines.
  • Interface with engineering, construction, automation, quality, operations and maintenance teams.
  • Provide technical leadership to CQV engineers and contractors.
  • Ensure systems are delivered in accordance with project quality, safety and compliance requirements.

Requirements

  • Degree in Engineering or related field.
  • 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.
  • Excellent planning, coordination and leadership capabilities.
  • Willingness to work on-site within Europe as project demands require.

  • European Pharmaceutical Projects | Initial Assignment in Germany

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