CQV Engineer
CQV Engineer
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Job Description
Job Title: C&Q Engineer (Mid -Senior Level) Clean Utilities & Downstream Equipment
Location: TorontoON 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:
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Support the preparation and execution of commissioning and qualification (IQ/OQ) protocols for clean utilities and downstream equipment.
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Perform P&ID walkdowns loop checks component verifications and functional testing.
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Participate in FAT/SAT equipment installation verification punchlist tracking and issue resolution.
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Assist with generating turnover packages (TOPs) traceability matrices and related documentation.
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Collaborate with QA automation and construction teams to ensure systems are delivered per GMP and project standards.
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Document and escalate deviations and support resolution and closeout.
Systems in Scope:
Clean Utilities:
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Water for Injection (WFI)
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Clean steam
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Compressed air and process gases
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CIP/SIP systems
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Cleanroom HVAC systems
Downstream Equipment:
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Chromatography skids
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Tangential Flow Filtration (TFF) units
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Buffer prep and hold tanks
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Centrifuges
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Formulation vessels and associated skids
Qualifications:
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Bachelors degree in Engineering Life Sciences or related technical field.
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5 years of experience in C&Q within pharmaceutical or biotech GMP facilities.
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Proven experience with clean utility systems and downstream manufacturing equipment.
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Proficiency with Kneat for protocol development execution and documentation.
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Familiarity with P&IDs engineering documentation and protocol execution standards.
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Understanding of cGMP ASTM E2500 and risk-based C&Q practices.
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Strong communication organization and technical writing skills.
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Collaborative mindset and ability to work effectively within cross-functional teams.
Preferred Experience:
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Project experience in greenfield or facility expansion projects.
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Exposure to DeltaV SCADA or building management/automation systems.
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Experience using commissioning tracking tools or turnover documentation systems.
Employment Type
Full Time
