CQV Engineer

Job Title: C&Q Engineer (Mid -Senior Level) Clean Utilities & Downstream Equipment
Location: Greater Raleigh Area, NC 
Industry: Pharmaceutical Manufacturing
Employment Type: Full-Time or Contract

Position Summary:

We are looking for a mid- to senior-level Commissioning & Qualification (C&Q) Engineer to support project execution at a pharmaceutical manufacturing facility in the Greater Raleigh area. This position is part of a project team focused on delivering commissioning and qualification activities for clean utility systems and downstream process equipment.

This is a field-based, execution-oriented role. The ideal candidate will have hands-on experience with GMP systems, familiarity with clean utilities and downstream process equipment.

Key Responsibilities:

Commissioning & Qualification:

• Support the preparation and execution of commissioning and qualification (IQ/OQ) protocols for clean utilities and downstream equipment.

• Perform P&ID walkdowns, loop checks, component verifications, and functional testing.

• Participate in FAT/SAT, equipment installation verification, punchlist tracking, and issue resolution.

• Assist with generating turnover packages (TOPs), traceability matrices, and related documentation.

• Collaborate with QA, automation, and construction teams to ensure systems are delivered per GMP and project standards.

• Document and escalate deviations and support resolution and closeout.

Systems in Scope:

Clean Utilities:

• Water for Injection (WFI)

• Clean steam

• Compressed air and process gases

• CIP/SIP systems

• Cleanroom HVAC systems

Downstream Equipment:

• Chromatography skids

• Tangential Flow Filtration (TFF) units

• Buffer prep and hold tanks

• Centrifuges

• Formulation vessels and associated skids

Qualifications:

• Bachelors degree in Engineering, Life Sciences, or related technical field.

• 5+ years of experience in C&Q within pharmaceutical or biotech GMP facilities.

• Proven experience with clean utility systems and downstream manufacturing equipment.

• Proficiency with Kneat for protocol development, execution, and documentation.

• Familiarity with P&IDs, engineering documentation, and protocol execution standards.

• Understanding of cGMP, ASTM E2500, and risk-based C&Q practices.

• Strong communication, organization, and technical writing skills.

• Collaborative mindset and ability to work effectively within cross-functional teams.

Preferred Experience:

• Project experience in greenfield or facility expansion projects.

• Exposure to DeltaV, SCADA, or building management/automation systems.

• Experience using commissioning tracking tools or turnover documentation systems.

Join our team and play a critical role in supporting the startup and qualification of essential GMP systems for a leading pharmaceutical client in the Greater Raleigh area. Opportunities are available for both full-time and contract roles.