锦鲤求职岗位描述
Responsibilities
Provide strategic leadership for engineering, automation and validation functions to ensure GMP compliance, operational excellence, capacity delivery, digital transformation and organizational capability development across sterile manufacturing operations.
1.Equipment Lifecycle Management
Develop lifecycle management strategies and engineering roadmaps to ensure safe, reliable and efficient operations. Lead maintenance, calibration, spare parts management, reliability improvement and asset optimization initiatives. Drive equipment modernization and establish engineering KPIs to achieve operational excellence.
2. Validation Management
Establish and maintain DP validation programs and Validation Master Plans. Lead qualification and validation activities for facilities, utilities, equipment and computerized systems through a lifecycle approach, ensuring sustainable compliance and inspection readiness.
3. Quality Systems & GMP compliance
Lead change controls, investigations, CAPA and quality risk management processes. Ensure robust risk-based decision making and effective resolution of complex engineering and compliance issues. Provide strategic leadership for GMP compliance and inspection readiness. Act as the engineering and validation subject matter expert during regulatory inspections and customer audits, ensuring effective remediation and sustainable compliance.
4. Lean & Digitalization
Drive digital transformation and operational excellence initiatives by leveraging CMMS, EMS, BMS, SCADA, MES and data analytics platforms. Promote TPM, Lean and reliability-centered maintenance programs to improve asset performance and productivity.
5.Capacity Expansion
Lead facility expansion, new production lines and capital investment projects from concept through commercialization. Oversee URS development, vendor selection, FAT/SAT, commissioning, qualification and project delivery while ensuring quality, timeline and budget objectives are achieved.
6. Leadership & Organization Development
Lead and develop engineering, automation, utility and validation organizations through talent development, succession planning and performance management. Foster a high-performance culture and strong cross-functional collaboration to support business growth.
7.EHS & Engineering Risk Management
Provide leadership for engineering safety, contractor management, risk mitigation and business continuity programs to ensure safe and sustainable operations.
8. Utilities & Facilities Management support
Support utility and facility management programs, ensuring reliable operation of WFI, clean steam, HVAC and cleanroom systems while supporting business growth and sustainability objectives.
9. Technology Transfer & Commercialization Support
Provide engineering and validation leadership for technology transfer, process validation, commercialization and global regulatory submissions.
Requirement
Bachelor degree or above in Mechanical, Electrical, Automation or Pharmaceutical Engineering
10+ years of pharma equipment/validation experience; familiar with FDA, EU GMP, ISPE and GAMP5; good English communication skills.