Senior CQV Engineer – Pharma Validation & Commissioning

CAI; Dublin; On-site; EUR 90,000 - 120,000; Full time

Job summary

CAI delivers expert commissioning, qualification, validation and consulting services to the global life sciences industry. We are seeking experienced Senior CQV Engineers to support major pharmaceutical manufacturing expansion projects across Europe.

You will lead CQV activities across process, utility and facility systems and collaborate with engineering, construction, automation, quality and operations teams to deliver compliant systems from installation through qualification and operational

Qualifications

• CQV experience in pharmaceutical/biotech manufacturing.
• Good understanding of GMP regulations and qualification practices.
• Experience with FAT/SAT and vendor package reviews.
• Knowledge of ASTM E2500 qualification methodologies.

Responsibilities

• Lead 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 lists 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

Strong troubleshooting

Stakeholder management

Communication skills

Problem solving

Education

Degree in Engineering or Science

Tools

Kneat

Job description

CAI delivers expert commissioning, qualification, validation and consulting services to the global life sciences industry. We are seeking experienced Senior CQV Engineers to support major pharmaceutical manufacturing expansion projects across Europe.

You will lead CQV activities across process, utility and facility systems and collaborate with engineering, construction, automation, quality and operations teams to deliver compliant systems from installation through qualification and operational