CQV Engineer
- ON, Canada
- Ontario, Canada, Canada
$45 to $50 CAD / hour · Contract
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Job details
- Pay
- $45 to $50 CAD / hour
- Job type
- Contract
- Apply by
- Experience
- 3+ years of CQV experience within the pharmaceutical or biotechnology industry.
- Posting language
- English
- Posted
Original job description
Job Title: CQV Engineer
Company: Intellectt Inc.
Location: Ontario, Canada
Employment Type: Contract : 12+ Months
Description:
Our client is seeking a CQV Validation Engineer to support commissioning, qualification, and validation activities within a GMP-regulated pharmaceutical manufacturing environment. The role involves executing qualification protocols, validating pharmaceutical manufacturing equipment and utility systems, and ensuring compliance with applicable GMP and regulatory requirements.
Job Responsibilities:
- Execute commissioning, qualification, and validation (CQV) activities for pharmaceutical manufacturing equipment, facilities, and utility systems.
- Develop, review, and execute IQ, OQ, and PQ protocols.
- Perform qualification of GMP utility systems, including HVAC, purified water (PW), Water for Injection (WFI), clean steam, and compressed air.
- Support equipment qualification, system walkdowns, functional testing, and field verification.
- Execute and document FAT and SAT activities.
- Prepare validation protocols, test scripts, execution reports, and qualification summary reports.
- Identify and document deviations, discrepancies, and protocol exceptions.
- Support change control, deviation management, and CAPA activities.
- Ensure qualification documentation meets GMP and regulatory requirements.
- Collaborate with Engineering, Quality Assurance, and Manufacturing teams.
Required Qualifications:
- Bachelor's degree in Mechanical, Chemical, Electrical, or a related Engineering discipline.
- 3+ years of CQV experience within the pharmaceutical or biotechnology industry.
- Hands-on experience executing IQ, OQ, and PQ protocols.
- Experience qualifying pharmaceutical manufacturing equipment and GMP utility systems.
- Knowledge of HVAC, PW, WFI, clean steam, and compressed air systems.
- Understanding of GMP, GAMP 5, and ASTM E2500 guidelines.
- Experience with FAT, SAT, deviations, and change control.
- Familiarity with Kneat, ValGenesis, or MasterControl is preferred.
Pay Scale: Anticipated hourly pay range: Based on experience and qualifications: CA$45 - CA$50
Benefits: To be determined based on applicable Canadian employment and benefit plans.
More about this job
Responsibilities
Execute CQV activities and IQ, OQ, and PQ protocols for pharmaceutical manufacturing equipment, facilities, and utility systems, including HVAC, water, clean steam, and compressed air systems. Document testing and qualification results, manage deviations and change controls, and collaborate with Engineering, Quality Assurance, and Manufacturing teams to ensure GMP and regulatory compliance.
Requirements
Requires a bachelor's degree in Mechanical, Chemical, Electrical, or a related Engineering discipline and at least three years of CQV experience in the pharmaceutical or biotechnology industry. Candidates should have hands-on IQ/OQ/PQ and equipment and utility qualification experience, knowledge of GMP, GAMP 5, and ASTM E2500, and experience with FAT, SAT, deviations, and change control; familiarity with Kneat, ValGenesis, or MasterControl is preferred.
Skills
- Commissioning, Qualification, And Validation (CQV)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- GMP Utility Systems
- HVAC
- Purified Water (PW)
- Water For Injection (WFI)
- Clean Steam
- Compressed Air
- FAT And SAT
- Protocol Execution
- Deviation Management
- Change Control
- CAPA
- GMP Compliance
Visa sponsorship
Not detected in the job text
Categories
- Engineering
- Manufacturing
- Science & Research
Keywords
- Commissioning, Qualification, And Validation (CQV)
- Pharmaceutical Manufacturing
- Biotechnology
- Good Manufacturing Practice (GMP)
- GAMP 5
- ASTM E2500
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- HVAC
- Purified Water (PW)
- Water For Injection (WFI)
- Clean Steam
- Compressed Air
- Factory Acceptance Testing (FAT)
- Site Acceptance Testing (SAT)
- Equipment Qualification
- Utility Systems
- System Walkdowns
- Functional Testing
- Field Verification
- Validation Protocols
- Test Scripts
- Deviation Management
- Change Control
- Corrective And Preventive Action (CAPA)
- Kneat
- ValGenesis
- MasterControl