Job Title: CQV Engineer Clean Utilities
Location: Greater Chicago Area, IL (within one hour driving distance of Chicago)
Experience Required: 5+ years
Employment Type: 12+ months Contract
This is a strong opportunity for an experienced engineer to join a growing technical team focused on pharmaceutical and biopharmaceutical facility projects. The role involves hands-on work with design, commissioning, qualification, and start-up of clean utility systems and related process infrastructure. You'll work closely with other engineers, clients, and contractors to ensure that systems are designed, installed, and qualified according to cGMP and regulatory standards.
Key ResponsibilitiesProvide technical expertise in the design, installation, commissioning, qualification, and operation of clean utility systems such as:
Purified Water (PW)
Water for Injection (WFI)
Clean Steam (CS)
Heating, Ventilation & Air Conditioning (HVAC)
Process Compressed Air (CA) and Gases
Lead the development of key project deliverables , including:
Process Flow Diagrams (PFDs)
Piping & Instrumentation Diagrams (P&IDs)
Equipment and distribution layouts
Design Qualification (DQ)
Factory Acceptance Testing (FAT) documents
Commissioning Test Plans and Checklists
Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documentation
Support detailed design and field installation phases; execute and review commissioning and qualification protocols.
Act as a technical subject matter expert (SME) for clean utility design and operations, ensuring compliance with cGMP, mechanical standards, and industry best practices.
Oversee the procurement, field installation, commissioning, and qualification of equipment and systems throughout the project lifecycle.
Support the development of Project Validation Plans (PVPs) and risk-based qualification strategies in line with ASTM E-2500 or ISPE ICQ methodologies.
Coordinate with cross-functional teams to conduct design reviews, track project progress, and facilitate technical decisions.
Occasionally travel to vendor sites for Factory Acceptance Tests (FATs) or client meetings.
Provide on-site support during construction, commissioning, and validation phases, including work during planned shutdowns or extended hours when necessary.
Maintain compliance with site safety protocols and PPE requirements during field visits.
May participate in client relations, project scheduling, budgeting, and technical support for proposals or new business opportunities.
Supervise contractors during system testing and qualification phases.
Perform other related duties as assigned based on project workload and requirements.
Bachelor's degree in Mechanical, Electrical, or Chemical Engineering (or related discipline).
Minimum 5 years of experience in commissioning, qualification, and validation (CQV) of clean utility systems in the pharmaceutical or biotech industry .
Strong understanding of cGMP requirements and regulatory expectations for pharmaceutical operations.
Proven expertise in pharmaceutical-grade water systems (generation, storage, and distribution).
Familiarity with Risk-Based Commissioning & Qualification practices (ASTM E-2500, ISPE ICQ).
Experience with process control systems commissioning and qualification is an advantage.
Strong leadership and mentorship abilities - able to guide junior engineers and support team performance.
Excellent multitasking and organizational skills to manage multiple projects concurrently.
Ability to work both independently and collaboratively in a fast-paced, project-driven environment .
Willingness to travel occasionally for client or vendor site visits.
Compliance with client site requirements, including safety and vaccination policies where applicable.