About WuXi Biologics
We are a world-class biologics services provider, offering end-to-end solutions from discovery to commercialization. Our mission is to accelerate and transform discovery, development, and manufacturing in the fast-growing field of biologics to benefit patients worldwide.
Job Description
We are seeking an experienced CQV Engineer (Thermal Mapping) to join our team. As a CQV Engineer, you will be responsible for thermal mapping activities for upstream and downstream packages to enable start-up of the processing facility and 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.
Requirements
* 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 colleagues.
* Excellent problem-solving and troubleshooting skills.
* Flexible approach to work and a positive attitude.
What We Offer
* Bonus
* Pension
* Sports & Social Club
* VHI