Thermal Validation & CQV Engineer

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 to ensure GMP compliance and inspection readiness.

• Promote continuous improvement and provide mentorship and guidance to junior validation staff.

• Kaye AVS v1.4+ (or equivalent) for thermal validation and data acquisition.

• Kneat (paperless validation) and Veeva Vault for documentation management.

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

• 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.

• 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.

• 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.