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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:
Start: Asap
Duration: 6 months
Capacity: 5 days per week
Location: Liestal (CH)
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