About this role
About the Role BioNTech Nantong is seeking a Validation Engineer focused on facility, utilities, and process equipment validation across the plant. The role ensures compliant validation programs, risk assessment, and timely delivery of validation documentation to support manufacturing operations. What You'll Do
- Maintain the factory system validation processes.
- Develop validation plans for facilities, utilities, and process equipment and ensure their successful execution.
- Conduct validation risk assessments, develop validation plans and reports for facilities, utilities, and process equipment.
- Review supplier validation documents and perform gap analyses.
- Coordinate and manage validation activities for facilities, utilities, and process equipment, and participate in validation testing.
- Assist with the implementation and management of other equipment qualification/validation activities.
- Assist with quality events related to deviations, changes, CAPA, etc.
- Perform other duties assigned by superiors. What We're Looking For
- Bachelor's degree or above in bioengineering, biotechnology or other pharmaceutical-related disciplines.
- At least 6 years of validation-related work experience in a pharmaceutical company; biopharma experience preferred.
- Familiar with pharmaceutical validation systems, regulatory requirements and related workflows; able to independently perform validation work.
- English CET-6 or above; strong listening, speaking, reading, and writing; able to work in English.
- Strong sense of responsibility, good communication and coordination skills, and problem analysis and solving abilities.