Not specified (assume hybrid based on typical industry practices).
8-10 years drug product manufacturing experience
Aseptic processing operational support expertise
3-5 years people management experience
The Operations Support Principal Engineer at Wuxi Biologics will be instrumental in the startup of a new aseptic manufacturing facility, focusing on operational readiness and compliance with regulatory standards. The role includes responsibilities in managing operational staff, developing procedures, and interfacing with clients during new product introductions
Job Summary
This role is critical for supporting the startup of a state-of-the-art aseptic manufacturing facility with multiple production lines.
The incumbent will lead high-performing teams to ensure efficient execution of critical process steps while maintaining strict adherence to regulatory standards.
Responsibilities include managing technology transfer, new product introduction projects, and overseeing process validation followed by product approval inspections.
Matching Summary
Match Score: 85
The Operations Support Principal Engineer at Wuxi Biologics will be instrumental in the startup of a new aseptic manufacturing facility, focusing on operational readiness and compliance with regulatory standards. The role includes responsibilities in managing operational staff, developing procedures, and interfacing with clients during new product introductions.
Skills & Requirements
Must-have
8-10 years drug product manufacturing experience
Aseptic processing operational support expertise
3-5 years people management experience
SOP and Master Batch Record development
Regulatory compliance with FDA EMA PIC/S ICH
Nice-to-have
Experience in fast-paced CDMO environment
Master's degree or MBA qualification
Strong client interface and interpersonal skills
Travel availability for overseas training
Key Requirements
Bachelor's degree in Pharmaceutical Sciences or related field
8-10 years in drug product manufacturing
3-5 years of people management experience
Direct experience in formulation sterilization and preps
Mastery of Quality Management System tools like SAP