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

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.

• 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:

• 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

• 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.

• 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.