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 wh...