Job Description:
The Thermal Systems Validation Engineer will be responsible for preparing and monitoring technical project documentation, as well as validating the status of thermal systems equipment across the organization.
Key Responsibilities:
* Draft, review, and approve validation documentation
* Manage contractors in accordance with site procedures
* Oversee, witness, and execute requalification activities on-site thermal systems
* Participate in validation risk assessments to determine testing requirements for equipment changes or new equipment
* Support sustaining and project validation activities across drug substance and drug product areas
Requirements:
* 5+ years of experience in a validation role in the pharmaceutical/biotechnology industry
* Good knowledge of EN285 and stem sterilization system kill kinetics
* Good knowledge of CTU thermal mapping requirements
* Ability to work effectively with various departments and resolve issues in a structured manner
Preferred Qualifications:
* Understanding of ISO 14644 and its application in aseptic manufacturing
* Knowledge of VHP decontamination systems