Job Title: CQV Engineer (Thermal Mapping)
About Wu Xi Biologics
We are a world-class biologics services provider, serving global clients in the biopharmaceutical and healthcare industries.
Mission
To accelerate and transform discovery, development, and manufacturing in the fast-growing field of biologics to benefit patients worldwide.
Our Presence
We have sites/offices in China, US, EU, Asia, and Israel.
Career Opportunity
As CQV Engineer (Thermal Mapping), you will be responsible for thermal mapping activities for the upstream and downstream packages to enable start-up of the processing facility and for the ongoing activities during sustaining operations.
Responsibilities
* Review protocols/reports for equipment commissioning & qualification activities on-site, including URS, Risk Assessments, DQ, FAT, SAT, IOQ, PQ.
* Coordinate/perform all 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 the requirements of validation policies, guidelines, site validation master plan, and GMP.
* Sterilization/sanitization validations site-wide, as required.
* Temperature distribution studies site-wide, as required.
* Coordinate/perform other performance qualification and re-qualification/re-validation studies, as relevant.
* Generation of reports/analysis of data against pre-determined criteria to GMP standards.
Your Profile
* A degree in a life-science/engineering related discipline is required.
* 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 your colleagues.
* Excellent problem-solving and troubleshooting skills.
* Flexible approach to work and a positive attitude.