As a CQV Engineer (Thermal Mapping) at Wu Xi Biologics, you will be responsible for ensuring the thermal mapping activities of upstream and downstream packages to enable the start-up of processing facilities and ongoing operations during sustaining periods.
Responsibilities:
* Review protocols/reports for equipment commissioning & qualification activities on-site, including URS, risk assessments, DQ, FAT, SAT, IOQ, and PQ.
* Coordinate/perform temperature mapping and validation of equipment such as fridges, freezers, autoclaves, incubators, stability cabinets, and SIP systems.
* Maintain SOPs/WIs associated with qualification & validation studies.
* Ensure project-related work is carried out in accordance with validation policies, guidelines, site validation master plans, and GMP requirements.
* Perform sterilization/sanitization validations site-wide and temperature distribution studies as required.
* Coordinate/perform other performance qualification and re-qualification/re-validation studies as relevant.
* Generate reports/analysis of data against pre-determined criteria to GMP standards.
Requirements:
* A degree in a life-science/engineering related discipline.
* Minimum of 3 years experience in thermal mapping.
* A good understanding of the bio-pharmaceutical industry, including GMP and relevant validation requirements.
* Excellent communication, interpersonal, and presentation skills.
* Collaborative and inclusive approach to work and colleagues.
* Excellent problem-solving and troubleshooting skills.
* Flexible approach to work and positive attitude.
* Autonomous and self-starter who can drive actions forward.
* Demonstrate strong ethics in adhering to company procedures and policies, regulatory standards, and customer expectations.