CQV Engineer

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

Location : T oronto,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.

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 :

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.