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Job Title: CQV Engineer (Pharmaceutical)

Location: Ottawa, Canada - Onsite

Duration: 12 Months - on W2

Job Description: Our client, a leading pharmaceutical organization, is seeking an experienced CQV Engineer to support commissioning, qualification, and validation activities for GMP-regulated manufacturing systems and equipment. This role will be responsible for ensuring that facilities, utilities, equipment, and processes are designed, installed, tested, and operated in compliance with regulatory and quality standards.

Key Responsibilities:

- Lead and execute CQV lifecycle activities including Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for process equipment, utilities, and facility systems.
- Develop, review, and approve validation deliverables such as Validation Master Plans (VMP), protocols, test scripts, and summary reports.
- Support commissioning activities including FAT/SAT coordination, field verification, and turnover documentation.
- Perform risk assessments (e.g., FMEA) and implement risk-based validation strategies in alignment with regulatory expectations.
- Ensure compliance with cGMP, Health Canada, FDA, and ICH guidelines throughout all validation activities.
- Collaborate with cross-functional teams including Engineering, Quality Assurance, Manufacturing, and external vendors/contractors.




- Review and approve engineering documents such as P&IDs;, URS, FS/DS, and as-built drawings to ensure validation readiness.
- Support deviation investigations, CAPA implementation, and change control activities related to CQV scope.
- Maintain documentation in accordance with data integrity (ALCOA+) principles and audit readiness requirements.
- Provide on-site support during equipment installation, startup, and troubleshooting activities.

Required Qualifications:

- Bachelor’s degree in Engineering, Life Sciences, or a related technical field.
- 5+ years of experience in CQV/Validation within the pharmaceutical or biopharmaceutical industry.
- Solid experience with GMP-regulated environments and validation lifecycle methodologies.
- Hands-on experience with process equipment, clean utilities (WFI, Clean Steam, HVAC), and facility qualification.
- Familiarity with regulatory requirements (Health Canada, FDA, EU GMP, ICH).
- Experience with Kneat, Val Genesis, or similar validation management systems is a plus.
- Strong technical writing, documentation, and communication skills.

Preferred Skills:

- Experience supporting greenfield/brownfield projects or facility expansions.
- Knowledge of automation systems (SCADA, PLC) and CSV is an added advantage.
- Ability to manage multiple projects and work effectively in a fast-paced environment.

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📌 Validation Engineer - CQV (Ottawa)
🏢 Intellectt
📍 Ottawa