About the role
About The Job 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.
Clean Utilities Systems in Scope:
- 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.
About PharmEng Technology
PharmEng Technology is a leading global provider of technical services and solutions to the pharmaceutical, biotechnology, and healthcare industries. With over 25 years of experience, we specialize in Commissioning, Qualification, and Validation (CQV) services for facilities, utilities, equipment, and processes.
Our team of highly skilled professionals brings a wealth of industry expertise and knowledge to every project, ensuring that our clients receive the highest quality services and solutions. We pride ourselves on our ability to provide flexible, innovative, and cost-effective solutions that meet our clients' unique needs and challenges.
At PharmEng Technology, we are committed to delivering excellence in everything we do. We work closely with our clients to understand their goals and objectives and develop customized solutions that deliver measurable results. Our focus on quality, safety, and compliance ensures that our clients can trust us to meet their most critical needs.
As a trusted partner to some of the world's largest pharmaceutical companies, we have a proven track record of success in delivering high-quality technical services and solutions that drive operational efficiency, reduce costs, and enhance overall performance. We are dedicated to helping our clients succeed in an ever-evolving and highly competitive industry.
At PharmEng Technology, we are passionate about what we do, and we are committed to delivering excellence in everything we do.
Specialties: PharmEng Technology specializes in the planning, design, construction, and validation of Health Care, Laboratory, API Pharmaceutical and Biotechnology facilities and equipment, including computer systems. We provide professional services that meet both regulatory and business demands, following current Good Manufacturing Practices (cGMP), Good Engineering Practices (GEP), and Good Laboratory Practices (GLP).
About the role
About The Job 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.
Clean Utilities Systems in Scope:
- 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.
About PharmEng Technology
PharmEng Technology is a leading global provider of technical services and solutions to the pharmaceutical, biotechnology, and healthcare industries. With over 25 years of experience, we specialize in Commissioning, Qualification, and Validation (CQV) services for facilities, utilities, equipment, and processes.
Our team of highly skilled professionals brings a wealth of industry expertise and knowledge to every project, ensuring that our clients receive the highest quality services and solutions. We pride ourselves on our ability to provide flexible, innovative, and cost-effective solutions that meet our clients' unique needs and challenges.
At PharmEng Technology, we are committed to delivering excellence in everything we do. We work closely with our clients to understand their goals and objectives and develop customized solutions that deliver measurable results. Our focus on quality, safety, and compliance ensures that our clients can trust us to meet their most critical needs.
As a trusted partner to some of the world's largest pharmaceutical companies, we have a proven track record of success in delivering high-quality technical services and solutions that drive operational efficiency, reduce costs, and enhance overall performance. We are dedicated to helping our clients succeed in an ever-evolving and highly competitive industry.
At PharmEng Technology, we are passionate about what we do, and we are committed to delivering excellence in everything we do.
Specialties: PharmEng Technology specializes in the planning, design, construction, and validation of Health Care, Laboratory, API Pharmaceutical and Biotechnology facilities and equipment, including computer systems. We provide professional services that meet both regulatory and business demands, following current Good Manufacturing Practices (cGMP), Good Engineering Practices (GEP), and Good Laboratory Practices (GLP).