CQV Utility Engineer

Role: CQV Utility Engineer

Company: Intellectt Inc

Location: Lebanon, IN

Employment Type: Contract – W2

Contract Duration: 12 months, with anticipated extensions

Description: Our client is seeking a CQV Utility Engineer to support a large-scale pharmaceutical capital program at an active GMP manufacturing facility. This hands-on role focuses on field execution of commissioning, qualification, and validation activities for clean and black utility systems, including Water for Injection (WFI), clean steam, HVAC, compressed air, and process gases.

Job Responsibilities

• Execute commissioning and qualification activities for clean and black utility systems, including water, steam, HVAC, and process gases.
• Develop, review, and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and supporting documentation.
• Perform P&ID walkdowns, loop checks, component verification, and functional testing.
• Support Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), equipment installation verification, punch list tracking, and issue resolution.
• Prepare and maintain turnover packages (TOPs), traceability matrices, and qualification records.
• Use Kneat or equivalent electronic quality management systems (eQMS) to manage, execute, and document qualification activities.
• Document deviations, support root cause investigations, and ensure timely resolution and closeout.
• Ensure compliance with applicable FDA, EMA, and other regulatory requirements while applying cGMP, ASTM E2500, and risk-based commissioning and qualification principles.

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical field.
• Minimum of 5 years of commissioning and qualification (C&Q) experience in pharmaceutical or biotechnology GMP facilities.
• Hands-on experience with clean utility systems, including WFI, clean steam, HVAC, and compressed gases.
• Proficiency in Kneat or comparable electronic quality management and protocol execution platforms.
• Strong working knowledge of P&IDs, engineering documentation, and GMP protocol standards.
• Understanding of cGMP, ASTM E2500, and risk-based commissioning and qualification frameworks.

Preferred Qualifications

• Experience supporting greenfield projects or major facility expansion capital programs.
• Exposure to DeltaV, SCADA, or building management and automation systems.
• Familiarity with commissioning tracking tools and electronic turnover documentation systems.
• Experience executing FAT activities to verify equipment functionality and performance.
• Previous experience in an embedded C&Q or CQV department within an owner/operator or EPCM environment.

Pay Scale: $60-$65/hr on W2 (Negotiable based on experience)

Benefits: Employees hired into this position are eligible for the following benefits, subject to applicable plan terms and eligibility requirements

Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.

Retirement Benefits: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.

Paid Time Off (PTO): No PTO is provided other than that required by applicable state and local laws.