Clean Utilities CQV Lead

EFOR; Limerick; On-site; EUR 85,000 - 110,000; Full time

Job summary

EFOR in Ireland seeks a Clean Utilities CQV Lead to oversee commissioning, qualification and validation of critical utility systems (WFI, purified water, clean steam, gases) supporting manufacturing. You will lead CQV activities, review URS and design docs, and ensure GMP compliance across projects.

The role requires engineering or scientific credentials, 7+ years CQV experience in pharma environments, and strong leadership plus report writing skills.

Qualifications

• CQV leadership experience for clean utility systems.
• Strong report writing and documentation skills.
• In-depth GMP/regulatory knowledge for clean utilities.

Responsibilities

• Lead CQV for clean utilities (Purified Water, WFI, Clean Steam, Pharmaceuticals Gases, etc.).
• Develop and implement qualification protocols and management plans for all utility systems.
• Coordinate system start-up, testing, and troubleshooting with engineering and vendors.
• Review and approve URS, design documentation, and commissioning records.
• Ensure compliance with GMP and regulatory requirements for clean utilities.
• Manage deviations resolutions and documentation of change controls.
• Support utility mapping and validation sampling plans.
• Liaise with stakeholders to ensure clean utility readiness for manufacturing.

Skills

CQV leadership

Report writing

GMP knowledge

Vendor coordination

Education

Engineering degree or scientific discipline

Job description

The Clean Utilities CQV Lead oversees commissioning, qualification, and validation of critical clean utility systems such as WFI, purified water, clean steam, compressed air, and gases supporting production activities.

Key Responsibilities:

• Lead CQV for clean utilities (Purified Water, WFI, Clean Steam, Pharmaceuticals Gases, etc.)
• Develop and implement qualification protocols and management plans for all utility systems.
• Coordinate system start-up, testing, and troubleshooting with engineering and vendors.
• Review and approve URS, design documentation, and commissioning records.
• Ensure compliance with GMP and regulatory requirements for clean utilities.
• Manage the resolution of deviations and documentation of change controls.
• Support utility mapping and validation sampling plans.
• Liaise with stakeholders to ensure clean utility readiness for manufacturing.

Requirements:

• Engineering degree or scientific discipline.
• Minimum 7 years’ CQV experience, specializing in clean utility systems in pharma environments.
• In-depth knowledge of regulations, guidelines, and best practices for clean utilities.
• Strong leadership, technical, and report-writing skills.