Thermal Validation 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).
BI (Biological Indicator) handling and exposure.
Cycle execution, data capture, and analysis.
Cycle optimization and performance qualification.
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.
4+ (or equivalent) for thermal validation and data acquisition.
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.
Technical Expertise
Thermal cycle development, heat penetration studies, and BI logistics.
Solid understanding of FAT/SAT, risk-based validation, FCCA, RTM, and CSV principles.
Strong knowledge of GMP/GLP/GDP/EHS and ALCOA+ data integrity standards.
Excellent skills in technical writing, data/statistical analysis, and problem-solving.
Experience with isolators, tunnels, vial washers, and biowaste systems.
Exposure to large capital projects and site-wide validation strategies.
continuous improvement mindset.
An international community bringing together more than 110 different nationalities
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
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.
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.
Brief Call : Our process typically begins with a brief virtual/phone conversation to get to know you! 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.