Role: Validation Engineer – Commissioning, Qualification & Validation (CQV)

Location: Ontario, Canada

Duration: 12 Months

Description: We are seeking an experienced Validation Engineer to support Commissioning, Qualification, and Validation (CQV) activities within a GMP-regulated pharmaceutical manufacturing environment. The role will focus on the qualification and validation of facilities, utilities, equipment, and manufacturing systems throughout the project lifecycle. The Validation Engineer will work closely with Engineering, QA, Manufacturing, Automation, and project teams to develop and execute CQV deliverables, support commissioning activities, and ensure systems are appropriately qualified for GMP use.

Key Responsibilities

- Develop and execute validation and CQV protocols, including IQ, OQ, and PQ.
- Support commissioning, qualification, and validation of pharmaceutical manufacturing equipment, facilities, utilities, and process systems.
- Prepare and review URS, qualification plans, protocols, test scripts, reports, and traceability matrices.
- Support FAT, SAT, equipment commissioning, P&ID; walkdowns, loop checks, and functional testing.
- Perform qualification activities for HVAC, WFI, clean steam, compressed gases, process utilities, tanks, skids, and manufacturing equipment.
- Review engineering and vendor documentation to ensure qualification readiness.
- Develop and execute risk assessments, impact assessments, and system classification activities.
- Document test results, investigate discrepancies, and support deviation, change control, and CAPA activities.




- Ensure validation documentation complies with GMP, GDocP, site procedures, and applicable regulatory requirements.
- Collaborate with QA and Engineering teams on protocol approvals, execution, review, and qualification closeout.
- Support system turnover, commissioning readiness, qualification readiness, and final validation package compilation.
- Participate in project meetings and coordinate CQV activities with internal teams, vendors, and contractors.

Required Skills

- 5+ years of experience in pharmaceutical/biotech validation, CQV, or qualification.
- Robust hands-on experience with IQ/OQ/PQ execution.
- Experience with commissioning and qualification of pharmaceutical equipment, utilities, and facilities.
- Strong knowledge of GMP and pharmaceutical validation lifecycle requirements.
- Experience with FAT/SAT, P&IDs;, loop checks, functional testing, and system turnover.
- Experience with risk-based qualification, impact assessments, deviations, change controls, and CAPA.
- Strong technical documentation and protocol/report writing skills.
- Ability to interpret P&IDs;, engineering drawings, equipment specifications, and vendor documentation.
- Experience working in cross-functional environments with QA, Engineering, Manufacturing, Automation, and vendors.
- Knowledge of Health Canada, FDA, and/or EU GMP requirements.
- Strong understanding of Good Documentation Practices (GDocP) and data integrity.
- Bachelor's degree in Engineering, Life Sciences, Biotechnology, Chemistry, or a related technical field.

📌 Senior Validation Engineer - Intellectt Inc (Ontario)
🏢 Intellectt
📍 Ontario