CQV Engineer

7 days ago

Toronto, Ontario, Canada PharmEng Technology Full time $90,000 - $120,000 per year


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.

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.


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