Validation supervisor/Manager

1. 01

   Support department head to establish the validation system and standards. Own the validation process, SOPs,protocol and report templates, risk assessment approach and factory test specifications. Build reusable validation libraries for sterile filling, solid dosage and other relevant equipment, and update practices in line with applicable GMP

and industry guidance.

2. 02

   Deliver projects and approve validationoutputs. Plan and coordinate factory pre-validation, on-site IQ/OQ, PQ support, changes and re-validation as applicable. Manage milestones, resources and technical issues across projects. Review and approve protocols, reports, risk assessments, deviations and CAPA records within assigned authority,ensuring accurate, traceable and compliant customer handover.

3. 03

   Engage regulators and manage inspection readiness. Contact with domestic drug regulatory authorities on equipment validation topics; discuss and interpret regulatory changes and their impact on oversight and qualification requirements, then translate relevant expectations into internal standards and project practices. Support customer GMP audits, FDA inspections and EU third-party audits; coordinate responses, risk assessments, corrective actions and closure of findings.

4. 04

   Lead the validation team and cross-functional capability. Plan work and capacity,manage performance, develop talent and deliver training in regulations, validation methods and testing. Work with Engineering, Assembly and Quality to embed compliance requirements in equipment design, controls and factory testing.

5. 05

   Support sales and product improvement. Provide validation input with technical proposals, bids and customer requirement reviews for domestic and international opportunities. Feedback project and audit lessons into R&D, design and production to improve equipment design and standard validation packages.

6. 06

   Support business priorities and special projects. Take on additional assignments or special projects, as agreed with the line manager, to support evolving business targets and company strategy. Qualifications and experiences

7. 01

   Bachelor’s or higher degree in pharmaceutical engineering, bioengineering, mechanical automation, quality management or a related field.

8. 02

   At least 8 years of pharmaceutical equipment validation experience and 3 years of team management experience. Pharmaceutical company experience is preferred.

9. 03

   Working knowledge of applicable China GMP, FDA and EU GMP expectations and ISPE guidance; ability to support customer and regulatory audits.

10. 04

    Fluent written and spoken English, including preparation and review of technical documents and direct discussion with overseas customers.

11. 05

    Strong project coordination, people leadership and cross-functional communication skills; ability to manage parallel projects and travel domestically or internationally as required.