Thermal Validation & CQV Engineer

Amaris Consulting; Toronto; On-site; CAD 110,000 - 150,000; Full time

Job summary

Amaris Consulting seeks an experienced Thermal Validation & CQV Engineer to lead and execute CQV activities across facilities, utilities, systems, and equipment in a GMP-regulated environment. You will develop and perform thermal validation for sterilization and decontamination processes, ensuring compliance and inspection readiness.

Ideal candidates have 6–10+ years in CQV/CSV roles with protocol ownership, cross-functional leadership, and strong documentation skills in a global pharma context.

Qualifications

• Experience leading CQV/CSV in GMP environments.
• Strong documentation and risk-based validation background.
• Experience with IOQ/PQ, FCCA, RTM and validation lifecycle.
• Proficiency with thermal validation methods and data analysis.
• Cross-functional collaboration with Operations, MSAT, Automation and Quality.

Responsibilities

• Lead and execute CQV activities for facilities, utilities and equipment.
• Author/review risk-based CQV docs: FCCA, RTM, DQ, IOQ/PQ, EM PQ and smoke studies.
• Plan and perform FAT/SAT and CSV activities as applicable.
• Conduct thermal validation using Kaye AVS; cycle development and data analysis.
• Validate sterilization/decontamination systems (autoclaves, SIP, isolators).
• Support annual validation programs, requalification and temperature mapping.
• Investigate deviations, perform root-cause analysis, and prepare inspection-ready reports.
• Own documentation, change controls, SOPs/WIs, and scheduling.
• Collaborate with Operations, MSAT, Automation, Engineering & Maintenance and Quality.
• Mentor junior validation staff and drive continuous improvement.

Skills

CQV/CSV

Thermal validation

Kaye AVS

Kneat

Veeva Vault

GMP/GDP/GLP

ALCOA+ data integrity

Technical writing

Data analysis

Education

Bachelor's degree in Engineering

Tools

Kaye AVS v1.4+

Kneat

Veeva Vault

Job description

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.

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!