Job Title

Role: CQV Engineer (Commissioning, Qualification & Validation)Location: Winnipeg, CanadaDuration: 12 Months ContractOverview: Our client, a leading pharmaceutical organization, is seeking an experienced CQV Engineer to support commissioning, qualification, and validation activities for manufacturing equipment, utilities, and facilities. The role will focus on ensuring systems are compliant with regulatory requirements and ready for GMP operations.Key ResponsibilitiesExecute commissioning and qualification (C&Q) activities for process equipment, clean utilities, and facility systems.Develop and review validation lifecycle documents including URS, DQ, IQ, OQ, PQ protocols and reports.Perform risk assessments (e.g., FMEA, risk-based validation approaches) aligned with regulatory expectations.Support startup, troubleshooting, and system integration during commissioning phases.Ensure compliance with cGMP, FDA, Health Canada, and ICH guidelines.Collaborate with cross-functional teams including Engineering, QA, Manufacturing, and Automation.Execute protocols (IQ/OQ/PQ) and document test results, deviations, and corrective actions.Lead or support deviation investigations, CAPA, and change control processes related to validation activities.Review and approve vendor documentation (FAT/SAT, manuals, test records).Support audit readiness and regulatory inspections.Required Skills & QualificationsBachelors degree in Engineering, Life Sciences, or related field.7+ years of experience in CQV within pharmaceutical or biotech industry.Strong knowledge of GMP regulations (FDA, Health Canada, EU Annex 15).Hands-on experience with equipment qualification and clean utility systems (HVAC, WFI, Clean Steam, Compressed Air).Experience with validation documentation and execution (IQ/OQ/PQ).Familiarity with risk-based validation methodologies.Strong understanding of data integrity (ALCOA+) principles.Excellent documentation, communication, and cross-functional collaboration skills.Preferred QualificationsExperience in sterile manufacturing or biologics facilities.Exposure to automation systems (PLC/SCADA) validation.Prior experience supporting regulatory audits and inspections.