CQV Clean Utilities / Water Systems
Job Title: CQV Engineer – Clean Utilities & Purified Water SystemsCompany: Inova (www.inova-sa.ch)Location: Basel Region, SwitzerlandContract Type: Full-time – On-site
About InovaInova 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.
Position OverviewWe 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.
Key Responsibilities
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
Profile Requirements
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 lifecycle approaches
Familiarity with ISPE Baseline Guides, ASTM E2500, and ASME BPE is a strong advantage
Experience reviewing P&IDs, functional specifications, equipment documentation, and engineering drawings
Strong troubleshooting and problem-solving capabilities in a project environment
Structured, autonomous, and quality-focused working style
Strong communication skills and ability to coordinate effectively with multidisciplinary teams, vendors, and clients
Fluent in English; German is a strong asset
Why Join Inova?
Work on major pharmaceutical engineering and CQV projects in the Basel life sciences ecosystem
Take ownership of critical Clean Utility and Purified Water qualification activities
Combine hands-on engineering expertise with GMP qualification and project execution
Collaborate with experienced Engineering, CQV, QA, and Automation specialists
Join a dynamic Swiss company that values technical excellence, autonomy, precision, and collaboration
Inova is an equal opportunity employer. We welcome diverse perspectives and are committed to fostering an inclusive workplace.