Senior CQV Engineer

CAI; Frankfurt; On-site; EUR 90,000 - 140,000; Full time

Job summary

CAI is seeking an experienced Senior CQV Engineer to support commissioning and qualification activities across pharma manufacturing projects in Europe, with a focus on process equipment, utilities, and facilities. You will collaborate with engineering, quality, and operations to ensure compliant systems from installation through qualification and readiness.

The role requires significant CQV exposure in pharmaceutical environments, strong GMP knowledge, and hands-on FAT/SAT experience.

Qualifications

• Degree in Engineering, Science or related technical discipline.
• Significant CQV experience within pharmaceutical/biotech manufacturing environments.
• Strong understanding of GMP regulations and qualification practices.
• Experience supporting large-scale capital projects.
• Familiarity with Kneat or equivalent electronic validation systems.
• Experience with FAT/SAT execution and vendor package review.
• Knowledge of risk-based qualification principles and ASTM E2500 methodologies.
• Strong troubleshooting, communication and stakeholder management skills.

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 engineering documentation including P&IDs, specifications, drawings and datasheets.
• Manage deviations, punch list items and commissioning observations through 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 where required.

Skills

CQV experience

GMP knowledge

FAT/SAT execution

Vendor coordination

Risk-based qualification

Kneat/validation systems

Communication

Stakeholder management

Education

Degree in Engineering/Science

Tools

Kneat

Job description

CAI delivers expert commissioning, qualification, validation and consulting services to the global life sciences industry.

We are currently looking for experienced Senior CQV Engineers to support major pharmaceutical manufacturing expansion projects across Europe.

Position Summary

The Senior CQV Engineer will support commissioning and qualification activities across manufacturing process equipment, clean utilities, facility systems and supporting infrastructure.

The successful candidate will work closely with project engineering, construction, automation, quality and operations teams to deliver compliant systems from installation through qualification and operational readiness.

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 engineering documentation including P&IDs, specifications, drawings and datasheets.
• Manage deviations, punch list items and commissioning observations through 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 where required.

Requirements

• Degree in Engineering, Science or a related technical discipline.
• Significant CQV experience within pharmaceutical or biotechnology manufacturing environments.
• Strong understanding of GMP regulations and qualification practices.
• Experience supporting large-scale capital projects.
• Familiarity with Kneat or equivalent electronic validation systems.
• Experience with FAT/SAT execution and vendor package review.
• Knowledge of risk-based qualification principles and ASTM E2500 methodologies.
• Strong troubleshooting, communication and stakeholder management skills.
• Future opportunities across Ireland, Netherlands, Switzerland and wider European life sciences projects.