CQV Engineer

About The Job CQV Engineer

Job Title: C&Q Engineer (Mid -Senior Level) Clean Utilities & Downstream Equipment

Location: Toronto,ON, CA & Raleigh, NC, USA

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. This position is part of a project team that delivers 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 and be familiar 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.
  
  

Clean Utilities Systems in Scope:

• 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

• Bachelor's 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.