PharmEng Nordic ApS
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:
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, punch‑list 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 escape deviations and support resolution and closeout.
Systems in Scope: Clean Utilities:
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
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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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:
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, punch‑list 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 escape deviations and support resolution and closeout.
Systems in Scope: Clean Utilities:
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
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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