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.
Author, review and execute commissioning and qualification documentation.
Review engineering documentation including P&IDs, specifications, drawings and datasheets.
Participate in risk assessments and quality reviews.
Coordinate with vendors, contractors and multidisciplinary project teams.
Mentor junior CQV resources where required.
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.
Future opportuniti.