Job Title: CQV Engineer – Clean Utilities & Purified Water SystemsCompany: Inova ( Basel Region, SwitzerlandContract Type: Full-time – On-siteAbout 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 ResponsibilitiesPlan, coordinate, and execute commissioning and qualification activities for Clean Utility systems, with a strong focus on Purified Water systemsSupport the qualification of PW generation, storage, and distribution loops, including treatment technologies such as RO, EDI, ultrafiltration, and sanitization systemsDevelop and review CQV documentation, including User Requirements Specifications (URS), risk assessments, commissioning plans, qualification protocols, test scripts, and final reportsExecute and/or supervise FAT, SAT, commissioning, IQ, OQ, and PQ activitiesVerify installation and functionality of equipment, instrumentation, piping, automation, alarms, and control systemsSupport qualification activities related to water quality, system performance, sanitization cycles, and distribution loop operationEnsure traceability between user requirements, design documentation, risk assessments, and qualification testingReview vendor documentation and coordinate qualification activities with equipment suppliers and engineering contractorsManage deviations, punch-list items, discrepancies, and qualification‑related issues through resolutionCollaborate closely with Engineering, QA, Automation, Operations, Maintenance, and Validation teamsEnsure CQV activities comply with applicable GMP requirements, EU GMP Annex 15, ISPE guidance, and internal quality proceduresSupport system handover, operational readiness, and transition from project execution into routine GMP operationContribute to continuous improvement of CQV methodologies, templates, and execution strategiesProfile RequirementsDegree in Chemical Engineering, Mechanical Engineering, Process Engineering, Biotechnology, Pharmaceutical Engineering, or a related technical disciplineMinimum 5 years of experience in Commissioning, Qualification & Validation (CQV) within the pharmaceutical, biotech, or life sciences industryStrong hands‑on experience with Clean Utilities, particularly Purified Water generation and distribution systemsGood understanding of pharmaceutical water treatment technologies, sanitary design principles, instrumentation, piping systems, and automationDemonstrated experience executing FAT, SAT, commissioning, IQ, OQ, and PQSolid knowledge of GMP, EU GMP Annex 15, risk‑based qualification principles, and CQV lifecycle approachesFamiliarity with ISPE Baseline Guides, ASTM E2500, and ASME BPE is a strong advantageExperience reviewing P&IDs, functional specifications, equipment documentation, and engineering drawingsStrong troubleshooting and problem‑solving capabilities in a project environmentStructured, autonomous, and quality‑focused working styleStrong communication skills and ability to coordinate effectively with multidisciplinary teams, vendors, and clientsFluent in English; German is a strong assetWhy Join Inova?Work on major pharmaceutical engineering and CQV projects in the Basel life sciences ecosystemTake ownership of critical Clean Utility and Purified Water qualification activitiesCombine hands‑on engineering expertise with GMP qualification and project executionCollaborate with experienced Engineering, CQV, QA, and Automation specialistsJoin a dynamic Swiss company that values technical excellence, autonomy, precision, and collaborationInova is an equal opportunity employer. We welcome diverse perspectives and are committed to fostering an inclusive workplace. #J-18808-Ljbffr
CQV Engineer - Clean Utilities & Water Systems in Basel Arbeitgeber: Inova Consulting
Inova ist ein hervorragender Arbeitgeber, der Ihnen die Möglichkeit bietet, eine Schlüsselrolle in strategischen Industrieintegrationsprojekten zu übernehmen. Mit einem Fokus auf Präzision, Autonomie und Zusammenarbeit fördert Inova eine positive Arbeitskultur, in der Sie mit erfahrenen Projekt-, Ingenieur-, Automatisierungs- und Qualitätsteams zusammenarbeiten können. Zudem profitieren Sie von umfangreichen Entwicklungsmöglichkeiten in einem dynamischen Umfeld, das sich auf die Zukunft der Lebenswissenschaften und Industrie konzentriert.
