CQV Engineer - Clean Utilities & Water Systems

Job Title: CQV Engineer – Clean Utilities & Purified Water Systems

Company: Inova ((Use the "Apply for this Job" box below).)

Location: Basel Region, Switzerland

Contract Type: Full-time – On-site

Inova is a Swiss consulting and engineering firm specializing in supporting life sciences industries through high-value expertise in engineering, commissioning & qualification, quality, compliance, and digital transformation.

We support our clients throughout the lifecycle of pharmaceutical facilities and critical systems, from design and project execution through commissioning, qualification, and operational readiness.

We are seeking an experienced CQV Engineer specialized in Clean Utilities and Purified Water Systems to support a pharmaceutical project in the Basel area.

In this role, you will be responsible for commissioning and qualification activities related to critical GMP utility systems, with a particular focus on Purified Water (PW) generation, storage, and distribution systems
.

You will work closely with Engineering, QA, Operations, Automation, and equipment suppliers to ensure that systems are properly designed, commissioned, qualified, and handed over in compliance with GMP requirements and project specifications.

The position requires a strong combination of hands‑on technical expertise, structured CQV execution, and the ability to coordinate activities across multiple project stakeholders.

• Plan, coordinate, and execute commissioning and qualification activities for Clean Utility systems
  , with a strong focus on Purified Water systems
• Support the qualification of PW generation, storage, and distribution loops
  , including treatment technologies such as RO, EDI, ultrafiltration, and sanitization systems
• Develop and review CQV documentation, including User Requirements Specifications (URS), risk assessments, commissioning plans, qualification protocols, test scripts, and final reports
• Execute and/or supervise FAT, SAT, commissioning, IQ, OQ, and PQ activities
• Verify installation and functionality of equipment, instrumentation, piping, automation, alarms, and control systems
• Support qualification activities related to water quality, system performance, sanitization cycles, and distribution loop operation
• Ensure traceability between user requirements, design documentation, risk assessments, and qualification testing
• Review vendor documentation and coordinate qualification activities with equipment suppliers and engineering contractors
• Manage deviations, punch-list items, discrepancies, and qualification‑related issues through resolution
• Collaborate closely with Engineering, QA, Automation, Operations, Maintenance, and Validation teams
• Ensure CQV activities comply with applicable GMP requirements, EU GMP Annex 15, ISPE guidance, and internal quality procedures
• Support system handover, operational readiness, and transition from project execution into routine GMP operation
• Contribute to continuous improvement of CQV methodologies, templates, and execution strategies

• Degree in Chemical Engineering, Mechanical Engineering, Process Engineering, Biotechnology, Pharmaceutical Engineering
  , or a related technical discipline
• Minimum 5 years of experience in Commissioning, Qualification & Validation (CQV) within the pharmaceutical, biotech, or life sciences industry
• Strong hands‑on experience with Clean Utilities
  , particularly Purified Water generation and distribution systems
• Good understanding of pharmaceutical water treatment technologies, sanitary design principles, instrumentation, piping systems, and automation
• Demonstrated experience executing FAT, SAT, commissioning, IQ, OQ, and PQ
• Solid knowledge of GMP, EU GMP Annex 15, risk‑based qualification principles, and CQV…