Lead CQV Engineer - Pharma Manufacturing & Validation

CAI; Ireland; Remote; EUR 70,000 - 120,000; Full time

Job summary

CAI is seeking experienced Senior CQV Engineers to back major pharmaceutical manufacturing expansions across Europe. The role covers commissioning and qualification of process equipment, clean utilities, facility systems, and supporting infrastructure.

You will collaborate with project engineering, construction, automation, quality and operations to deliver compliant systems from installation through qualification and operational readiness.

Qualifications

• Significant CQV experience in pharma/biotech manufacturing.
• Strong GMP regulations and qualification practices knowledge.
• Experience supporting large-scale capital projects.
• Familiarity with Kneat or similar electronic validation systems.
• Experience with FAT/SAT execution and vendor package review.
• Knowledge of risk-based qualification principles and ASTM E2500 methodologies.

Responsibilities

• Lead and execute CQV activities for process, utility and facility systems.
• Author, review and execute commissioning and qualification documentation.
• Support FATs, SATs, commissioning, startup and qualification activities.
• Perform field walkdowns and installation verification activities.
• Review P&IDs, specifications, drawings and datasheets.
• Manage deviations, punch lists and commissioning observations to closure.
• Participate in risk assessments and quality reviews.
• Support system turnover and operational readiness activities.
• Coordinate with vendors, contractors and multidisciplinary project teams.
• Mentor junior CQV resources as required.

Skills

CQV experience

GMP knowledge

Stakeholder management

Project execution

Communication

Education

Engineering degree

Science degree

Tools

Kneat

Job description

CAI is seeking experienced Senior CQV Engineers to back major pharmaceutical manufacturing expansions across Europe. The role covers commissioning and qualification of process equipment, clean utilities, facility systems, and supporting infrastructure.

You will collaborate with project engineering, construction, automation, quality and operations to deliver compliant systems from installation through qualification and operational readiness.