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Thermal Validation & CQV Engineer

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Amaris Consulting

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Location:
Canada , Toronto

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Category:
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Salary:

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Job Description:

We are seeking an experienced Thermal Validation & CQV Engineer to lead and execute Commissioning, Qualification, and Validation (CQV) activities across facilities, utilities, systems, and equipment in a GMP-regulated environment. You will be responsible for developing and performing thermal validation for sterilization and decontamination systems, ensuring compliance, accuracy, and inspection readiness throughout the validation lifecycle.

Job Responsibility:

  • Lead and execute CQV activities for facilities, utilities, and process equipment across routine operations and capital projects
  • Author and review risk-based C&Q documentation: FCCA, RTM, DQ, CTP, IOQ/PQ, EM PQ, smoke studies, and thermal validation protocols
  • Plan and perform FAT/SAT, critical test plans, and CSV activities where applicable
  • Perform thermal validation using Kaye AVS v1.4+ (or equivalent)
  • Validate sterilization and decontamination systems
  • Support annual validation programs
  • Investigate and document deviations and non-conformances
  • Own documentation and scheduling
  • Collaborate closely with Operations, MSAT, Automation, Engineering & Maintenance, and Quality teams
  • Promote continuous improvement and provide mentorship and guidance to junior validation staff

Requirements:

  • Bachelor’s degree in Engineering, Pharmaceutical Sciences, Microbiology, or a related discipline
  • 3–6 years of CQV/CSV/thermal validation experience in a GMP pharmaceutical or biotech environment (Consultant/Intermediate level)
  • Strong hands-on experience with thermal cycle development, heat penetration studies, and BI logistics
  • Strong hands-on experience with temperature mapping and smoke studies
  • Strong hands-on experience with IOQ/PQ execution and requalification activities
  • Solid understanding of FAT/SAT, risk-based validation, FCCA, RTM, and CSV principles
  • Proficiency in Kaye AVS systems and familiar with Kneat and/or Veeva Vault
  • Strong knowledge of GMP/GLP/GDP/EHS and ALCOA+ data integrity standards
  • Excellent skills in technical writing, data/statistical analysis, and problem-solving

Nice to have:

  • Expertise in VHP/depyrogenation and SIP/CIP qualification (complex/custom systems)
  • Experience with isolators, tunnels, vial washers, and biowaste systems
  • Exposure to large capital projects and site-wide validation strategies
  • Experience mentoring or upskilling junior engineers
  • continuous improvement mindset
What we offer:
  • An international community bringing together more than 110 different nationalities
  • An environment where trust is central: 70% of our leaders started their careers at the entry level
  • A strong training system with our internal Academy and more than 250 modules available
  • A dynamic work environment that frequently comes together for internal events (afterworks, team buildings, etc.)

Additional Information:

Job Posted:
March 03, 2026

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