CQV Engineer - Clean Utilities & Water Systems

Inova Consulting; Basel; Vor Ort; CHF 120.000 - 160.000; Vollzeit

Zusammenfassung

Inova is seeking an experienced CQV Engineer specialized in Clean Utilities and Purified Water systems to support a pharmaceutical project in the Basel area. You will lead commissioning and qualification activities, focusing on PW generation, storage, and distribution, and collaborate with Engineering, QA, Operations, Automation, and suppliers.

The role requires hands-on CQV execution, strong GMP knowledge, and the ability to coordinate across multi-disciplinary teams for successful handover to

Qualifikationen

• Degree in Chemical Engineering, Mechanical Engineering, Process Engineering, Biotechnology, Pharmaceutical Engineering or related technical discipline.
• Minimum 5 years of CQV experience within pharma, biotech, or life sciences.
• Strong hands-on experience with Clean Utilities and PW systems.
• Good understanding of pharmaceutical water treatment technologies, sanitary design, instrumentation, piping systems, and automation.
• 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 with multidisciplinary teams, vendors, and clients.
• Fluent in English; German is a strong asset.

Aufgaben

• Plan, coordinate, and execute commissioning and qualification activities for Clean Utility systems with a focus on PW systems.
• Support the qualification of PW generation, storage, and distribution loops including RO, EDI, ultrafiltration, and sanitization systems.
• Develop and review CQV documentation (URS, risk assessments, commissioning plans, qualification protocols, test scripts, 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 with Engineering, QA, Automation, Operations, Maintenance, and Validation teams.
• Ensure CQV activities comply with GMP requirements, EU GMP Annex 15, ISPE guidance, and internal 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.

Kenntnisse

CQV expertise

GMP knowledge

Cross-functional coordination

Fluent English

Ausbildung

Bachelor's degree in Chemical/Mechanical/Process Engineering or related

Tools

ISPE Baseline Guides

ASTM E2500

ASME BPE

Jobbeschreibung

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

Company: Inova (www.inova-sa.ch)

Location: Basel Region, Switzerland

Contract Type: Full-time – On-site

About Inova

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.

Position Overview

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.

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.