Biotech sales Jobs in Markham, ON

We are seeking a CQV Specialist to join our team onsite in North York, Ontario . The ideal candidate will bring proven hands-on experience in thermal validation and strong technical knowledge in Commissioning, Qualification, and Validation (CQV) within a GMP pharmaceutical or biotech environment . This role is fully onsite and supports both routine operations and capital projects to ensure systems, equipment, and processes comply with regulatory and quality standards.

Main Responsibilities

• Lead and execute Commissioning, Qualification, and Validation (CQV) activities for facilities, utilities, systems, and equipment.
• Author and review risk-based validation deliverables such as FCCA, RTM, DQ, IOQ, PQ, EM PQ, and thermal validation protocols (heat penetration, cycle development, ranking studies for moist / dry heat and VHP).
• Plan and perform FAT / SAT , critical test plans, and CSV where applicable.
• Conduct thermal validation using Kaye AVS v1.4+ (or equivalent) including thermocouple preparation / calibration, BI handling, cycle execution, and data analysis.
• Validate cycles and equipment such as autoclaves, sterilizers, isolators, tunnels, ovens, SIP, biowaste, and decontamination systems .
• Support startups, troubleshooting, decommissioning, and requalifications of new or modified systems.
• Manage and execute annual validation programs (smoke studies, requalifications, and temperature mapping).
• Investigate deviations, analyze data, and generate inspection-ready reports .
• Collaborate cross-functionally with Operations, Quality, Engineering, Automation, and MSAT teams.
• Contribute to continuous improvement and share best practices across CQV activities.

Requirements