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Greater Toronto Area, Canada MMR Consulting Full timeCommissioning & Qualifications (C&Q) Engineer/ Specialist MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical, and biotechnology industries. Its services include Engineering, Project Management, and other Consulting services. MMR’s Engineering expertise includes Process, Automation, Facilities engineering. Pharmaceutical...
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Greater Toronto Area, Canada MMR Consulting Full timeCommissioning & Qualifications (C&Q) Engineer/ Specialist MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical, and biotechnology industries. Its services include Engineering, Project Management, and other Consulting services. MMR’s Engineering expertise includes Process, Automation, Facilities engineering. Pharmaceutical...
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Greater Toronto Area, Canada MMR Consulting Full time $70,000 - $120,000 per yearCommissioning & Qualifications (C&Q) Engineer/ SpecialistMMR Consulting is an engineering and consulting firm specializing in the pharmaceutical, and biotechnology industries. Its services include Engineering, Project Management, and other Consulting services. MMR's Engineering expertise includes Process, Automation, Facilities engineering. Pharmaceutical...
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Toronto, On, Canada MMR Consulting Full timeCommissioning & Qualifications (C&Q) Engineer/ Specialist MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical, and biotechnology industries. Its services include Engineering, Project Management, and other Consulting services. MMR’s Engineering expertise includes Process, Automation, Facilities engineering. Pharmaceutical...
Commissioning, Qualification
4 weeks ago
Toronto, ON | Mission DescriptionWe are looking for passionate and skilled CQV Engineers to join our team and support a major multi-phase GMP program in Toronto. You will play a key role in ensuring that Facilities, Utilities, Systems, and Equipment are qualified and validated to meet the highest pharmaceutical and biotech standards.In this role, you will:Lead and execute Commissioning, Qualification, and Validation (CQV) activities across routine operations and capital projects.Author and review risk-based C&Q deliverables including FCCA, RTM, DQ, CTP, IOQ/PQ, EM PQ, smoke studies, and thermal validation protocols (heat penetration, cycle development, ranking studies for moist heat, dry heat, and VHP).Plan and execute FAT/SAT, critical test plans, and CSV activities for equipment and automation interfaces.Perform thermal validation using Kaye AVS v1.4+ (or equivalent): thermocouple prep/calibration, BI handling, cycle execution, data capture, and analysis.Validate cycles/equipment such as autoclaves, sterilizers, isolators, tunnels, ovens, vial washers, SIP systems, biowaste units, decontamination autoclaves, and sanitization systems.Support startup, decommissioning, troubleshooting, and requalification of systems.Execute annual programs including smoke studies, thermal validation, temperature mapping, and ISO recertifications.Investigate and document deviations/non-conformances, perform data analysis, and generate inspection-ready reports.Manage change controls, SOPs, PM lists, and documentation in Kneat or Veeva Vault; provide regular written updates to stakeholders.Collaborate closely with Operations, MSAT, Automation, Engineering, Maintenance, and Quality to maintain inspection readiness.Drive continuous improvement and mentor junior team members across validation activities.Tools/Platforms: Kneat (paperless validation), Veeva Vault, Kaye AVS v1.4+Profile Requirements Education:Bachelor’s degree in Engineering, Pharmaceutical Sciences, Microbiology, or a related technical field. Experience:We are hiring 10 professionals across different seniority levels to cover the full validation cycle — from equipment to process to computer systems.Consultant / Intermediate: 3–6 years of CQV/CSV/Thermal Validation experience in GMP Pharma/BiotechSenior: 6–10+ years, with ownership of protocols/reports and cross-functional leadership experienceSME / Lead: 10+ years, leading complex/custom validation programs and inspection preparation Technical Depth:Strong hands-on experience with IOQ/PQ, thermal cycle development, BI logistics, temperature mapping, smoke studies, EM PQ, and requalificationFamiliar with FAT/SAT, FCCA, RTM, DQ, risk-based validation, and CSVPractical use of Kaye AVS (v1.4+) or equivalent, Kneat, and/or Veeva Vault
