Department: Validation/Location: Wuhan, China

Job Responsibilities

1. Promote the safe operation of the company’s biotechnology facilities through personal initiative and compliance with company procedures.
2. Keep the verification status of the system directly affected in accordance with GMP. Review the factory acceptance and site acceptance test (FAT and SAT) documents prepared by the supplier.
3. Keep the verification status of the system directly affected in accordance with GMP. Review the factory acceptance and site acceptance test (FAT and SAT) documents prepared by the supplier.
4. Coordinate the development of process, cleaning and computerized system validation plans in collaboration with subject matter experts.
5. Implement validation and validation protocols in accordance with good document management practices and approved procedures. Prepare validation report.
6. Select and purchase equipment and consumables required to perform validation activities.
7. Develop standard operating procedures and related records covering the validation life cycle: risk assessment, urs, validation protocol, reports.
8. Develop standard procedures for the operation of test equipment used in validation testing, such as Kaye 2000 validation system.
9. Propose and close the deviation in time.
10. Identify verification requirements for proposed changes and corrective actions.
11. Comply with and continuously improve the company’s quality management system.
12. Draft system and component criticality assessment.
13. Lead validation risk assessment and document failure modes and mechanisms for controlling key quality attributes.
14. Review specifications for compliance with company quality and performance standards.

Job Requirements

1. Bachelor degree (preferably mechanical or chemical) plus at least 2 years of validation experience in pharmaceutical or medical device industry.
2. Experience in operation of pharmaceutical facilities, experience in establishment of plant facilities is preferred.
3. Good knowledge of engineering management practices, including documentation and operation of pharmaceutical facilities. Good understanding of GMP.
4. Familiar with good automated manufacturing practices (GAMP).
5. Good knowledge of pharmaceutical utility systems (such as PW, WFI, pure steam, compressed air and clean room HVAC), computerized systems, process equipment and analytical testing equipment.
6. Advanced document writing skills using Microsoft Office suite. Attention to detail, like to work in a highly structured way.
7. Strong communication skills in Chinese and English, able to communicate with the whole company and service providers, including understanding English technical documents.