Talent.com
Thermal Validation & CQV Engineer
Thermal Validation & CQV EngineerAmaris Consulting • Toronto, ON, CA
Thermal Validation & CQV Engineer

Thermal Validation & CQV Engineer

Amaris Consulting • Toronto, ON, CA
30+ days ago
Job type
  • Full-time
Job description

2 days ago Be among the first 25 applicants

Get AI-powered advice on this job and more exclusive features.

Who are we?

Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1,000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines : Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.

At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here’s what our recruitment process looks like :

Brief Call

Our process typically begins with a brief virtual / phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!

Interviews

The average number of interviews is 3 – the number may vary depending on the level of seniority required for the position. During the interviews, you will meet people from our team : your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris : our culture, our roots, our teams, and your career opportunities!

Case Study

Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem‑solving scenario, etc.

As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate’s shoes to ensure they have the best possible experience.

We look forward to meeting you!

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.

Key Responsibilities

  • 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 (heat penetration, cycle development, ranking studies; moist heat, dry heat, VHP).
  • Plan and perform FAT / SAT, critical test plans, and CSV activities where applicable (equipment / automation interfaces).

Perform thermal validation using Kaye AVS v1.4+ (or equivalent) :

  • Thermocouple preparation, calibration, and placement.
  • BI (Biological Indicator) handling and exposure.
  • Cycle execution, data capture, and analysis.
  • Cycle optimization and performance qualification.
  • Validate sterilization and decontamination systems, including : Autoclaves, isolators, tunnels, ovens, vial washers, SIP systems, biowaste and decontamination autoclaves, and sanitization systems.
  • Support annual validation programs : smoke studies, sterilizer / isolator / tunnel / oven / SIP requalification, and temperature mapping of controlled units.
  • Investigate and document deviations and non‑conformances, perform root cause analysis, and generate inspection‑ready validation reports.
  • Own documentation and scheduling, including change controls, SOPs / WIs, PM task lists, and regular reporting via Excel / PPT (Teams / Email).
  • Collaborate closely with Operations, MSAT, Automation, Engineering & Maintenance, and Quality teams to ensure GMP compliance and inspection readiness.
  • Promote continuous improvement and provide mentorship and guidance to junior validation staff.
  • Tools & Platforms

  • Kaye AVS v1.4+ (or equivalent) for thermal validation and data acquisition.
  • Kneat (paperless validation) and Veeva Vault for documentation management.
  • Profile Requirements

    Education

  • Bachelor’s degree in Engineering, Pharmaceutical Sciences, Microbiology, or a related discipline.
  • Experience By Level

  • Consultant / Intermediate : 3–6 years of CQV / CSV / thermal validation experience in a GMP pharmaceutical or biotech environment.
  • Senior : 6–10+ years with protocol / report ownership and cross‑functional leadership.
  • SME / Lead : 10+ years leading complex validation programs and supporting inspections.
  • Technical Expertise

    Strong hands‑on experience with :

  • Thermal cycle development, heat penetration studies, and BI logistics.
  • Temperature mapping and smoke studies.
  • 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.
  • Why choose us

  • 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.).
  • Amaris Consulting promotes equal opportunities. We are committed to bringing together people from diverse backgrounds and creating an inclusive work environment. In this regard, we welcome applications from all qualified individuals, regardless of sex, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.

    Seniority level

    Mid-Senior level

    Employment type

    Other

    Job function

    Quality Assurance

    Industries

    IT Services and IT Consulting

    Referrals increase your chances of interviewing at Amaris Consulting by 2x

    Get notified about new Validation Engineer jobs in Toronto, Ontario, Canada .

    We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

    #J-18808-Ljbffr

    Create a job alert for this search

    Thermal Validation CQV Engineer • Toronto, ON, CA

    Similar jobs
    Co-op QA Inspector : Hands-On Quality & Calibration

    Co-op QA Inspector : Hands-On Quality & Calibration

    S&C Electric Company • Toronto
    Full-time
    A leading electrical company in Toronto is looking for an Assistant QA Inspector (Co-op) who is passionate about quality assurance. The role involves verifying and measuring parts, calibrating shop ...Show more
    Last updated: 3 days ago • Promoted
    Quality Engineer

    Quality Engineer

    freelance.ca • Toronto, Canada
    Full-time
    If anyone is interested, please let me know.Roles & Responsibilities⦁ 4-6 years of hands-on experience in AI / ML engineering in cloud environments⦁ Strong proficiency in Python, SQL and ML framework...Show more
    Last updated: 30+ days ago • Promoted
    QC Analyst II – Cell Therapy QC (cGMP)

    QC Analyst II – Cell Therapy QC (cGMP)

    Apex Systems • Toronto
    Full-time +1
    A leading biotechnology firm in Toronto seeks a QC Analyst II for a 12-month contract focused on quality control testing for cell therapies. Responsibilities include conducting QC testing activities...Show more
    Last updated: 3 days ago • Promoted
    Senior Verification Engineer – Cloud ML Hardware

    Senior Verification Engineer – Cloud ML Hardware

    Amazon Web Services (AWS) • Toronto C6A, ON, Canada
    Full-time
    A leading cloud computing company is seeking a Sr.In this role, you will verify hardware and software solutions, develop comprehensive verification plans, and collaborate with cross-functional team...Show more
    Last updated: 16 days ago • Promoted
    Head of Model Quality & Validation

    Head of Model Quality & Validation

    Scotiabank • Toronto
    Full-time +1
    A leading financial institution in Canada is seeking a Manager, Model Quality for an 8-month contract in Toronto.This role involves ensuring model lifecycle compliance, leading testing efforts, and...Show more
    Last updated: 3 days ago • Promoted
    Reliability Engineer

    Reliability Engineer

    Cenovus Energy • Toronto, Canada
    Full-time
    Worker Type : EmployeeJob Post End Date : 01 / 31 / 2026 • •About this opportunity : • •Reporting to the Manager, Reliability Engineering, the Reliability Engineer will lead analysis on equipment failures, id...Show more
    Last updated: 7 days ago • Promoted
    Test Engineer - Pilot Plant & Product Validation

    Test Engineer - Pilot Plant & Product Validation

    Agri-Neo • Toronto
    Full-time
    A leading food safety solutions provider in Toronto is seeking a motivated Test Engineer to join its engineering team.The role involves supporting the product development process of new food safety...Show more
    Last updated: 3 days ago • Promoted
    Quality Engineer I

    Quality Engineer I

    TD Securities • Toronto
    Full-time
    TD is committed to providing fair and equitable compensation opportunities to all colleagues.Growth opportunities and skill development are defining features of the colleague experience at TD.Our c...Show more
    Last updated: 3 days ago • Promoted
    Engineer

    Engineer

    Tekgence Inc • Toronto
    Full-time
    Over 5 years of experience in Power system applications including Power Flow, State Estimator, Contingency analysis, Load Frequency Control(AGC), Dispatcher Training Simulator (DTS) with expertise ...Show more
    Last updated: 3 days ago • Promoted
    ASIC Verification Engineer 2

    ASIC Verification Engineer 2

    High Tech Genesis • Toronto, ON, CA
    Full-time
    At HTG, you’ll push boundaries with the latest tech and collaborate with a team that loves what they do.Be part of a design services company that is amongst the companies that lead the world in tec...Show more
    Last updated: 10 days ago
    Quality Engineer

    Quality Engineer

    Avery Dennison • Toronto
    Full-time
    Avery Dennison Corporation (NYSE : AVY) is a global materials science and digital identification solutions company that provides a wide range of branding and information solutions that optimize labo...Show more
    Last updated: 3 days ago • Promoted
    Staff SoC Verification Engineer

    Staff SoC Verification Engineer

    Arm • Toronto
    Full-time
    Principal Security Design Engineer at Arm.Arm's Solutions Engineering SoC Security Team is seeking creative and enthusiastic SoC Design Engineers. Our Arm Solutions Engineering SoC Security Team is ...Show more
    Last updated: 3 days ago • Promoted
    Quality Engineer I

    Quality Engineer I

    TD Bank • Toronto
    Full-time
    Work Location : • •Toronto, Ontario, Canada • •Hours : • •37.Line of Business : • •Technology Solutions • •Pay Details : • •$69,700 - $98,400 CADTD is committed to providing fair and equitable compensation opportu...Show more
    Last updated: 3 days ago • Promoted
    Senior ASIC Verification Engineer

    Senior ASIC Verification Engineer

    BTA Design Services • Toronto, ON, CA
    Full-time
    Quick Apply
    About Us : Headquartered in Ottawa, BTA Design serves the electronic design community in Canada and beyond, specializing in ASIC and FPGA design and verification, and embedded software development s...Show more
    Last updated: 30+ days ago
    Industrialization Validation Lead

    Industrialization Validation Lead

    Safran Group • Toronto
    Full-time
    Industrialization Validation Lead.Validates manufacturing process proposed by suppliers for new product industrialization in line with Safran requirements. Extracts and validates Production Part App...Show more
    Last updated: 1 day ago • Promoted
    Quality Continuous Improvement Engineer

    Quality Continuous Improvement Engineer

    Adecco Canada • Scarborough, Ontario, Canada
    Full-time +1
    Quick Apply
    Are you passionate about driving operational excellence, eliminating waste, and boosting efficiency? Do you thrive in fast-paced manufacturing environments where quality, innovation, and continuous...Show more
    Last updated: 5 hours ago • Promoted • New!
    Manager, Model Validation

    Manager, Model Validation

    TMX Group • Toronto
    Full-time +1
    Venture outside the ordinary - TMX Careers.The TMX group of companies includes leading global exchanges such as the Toronto Stock Exchange, Montreal Exchange, and numerous innovative organizations ...Show more
    Last updated: 3 days ago • Promoted
    Senior Quality Engineer

    Senior Quality Engineer

    freelance.ca • Toronto, Canada
    Full-time
    Location : Toronto, ON (Hybrid).Highly skilled and experienced Senior Guidewire QE Engineer to lead design| development| and implementation efforts for our Guidewire-based insurance platform.The ide...Show more
    Last updated: 1 day ago • Promoted