CQV Utilities

In this hands-on consulting role, you are responsible for the commissioning, qualification, and ongoing oversight of clean utility systems and controlled areas within a regulated manufacturing environment. You support the successful delivery of complex technical projects by ensuring utilities, rooms, and process gas systems are installed, tested, and operated in compliance with GMP expectations.

Key Responsibilities

• Lead commissioning and qualification activities for clean utilities, process gases, and controlled rooms

• Define and execute sampling and monitoring strategies for utility and environmental systems

• Coordinate internal teams and external vendors for testing, commissioning, and analytical services

• Prepare and maintain qualification documentation such as protocols, acceptance criteria, and summary reports

• Perform GMP risk assessments for quality-critical infrastructure and cleanroom utilities

• Own deviations and corrective actions in collaboration with Quality functions

• Act as subject matter expert for changes, investigations, training, and interfaces with QC

• Establish routine monitoring, trending, and continuous improvement programs for utilities and environments

Your Profile

• Several years of experience in CQV, microbiology, and lifecycle management of clean utilities, rooms, and process gas systems

• Proven background in commissioning, qualification, and monitoring within GMP-regulated facilities

• Strong knowledge of compliance frameworks (e.g. EU GMP, FDA, ICH, ISO, GAMP)

• Structured, hands-on, and solution-oriented with strong communication skills

• Fluent in German; English skills are an advantage

Requirements: