Thermal Validation & CQV Engineer

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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:

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!

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!

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 ever, 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!

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.

• 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…