Drug Product Technician
WuXi XDC
Job Description
KEY ACCOUNTABILITIES:The DP Technician is primarily responsible for performing routine preventive maintenance, predictive maintenance, unplanned repairs, and daily inspections on DP-area equipment, along with other equipment lifecycle management tasks assigned by superior, to ensure stable and reliable equipment operation. Project Construction, CQV and Startup Phase:Support installation, commissioning, equipment start-up activities, and execution of FAT/SAT and IOQ.Support commissioning test, punch list closures, deviation/variations resolutions, and change controls related to packing equipment.Support for start-up batches, technical troubleshooting, and first-of-a-kind process runs.Support technical clarifications, engineering changes, and ensure documentation completion. Operational Phase:Responsible for performing daily preventive maintenance, predictive maintenance, and routine inspections on DP-area equipment, ensuring scheduled maintenance is completed as planned.Responsible for resolving unplanned equipment failures with prioritized rapid response to minimize downtime; coordinate remote assistance with vendors when required.Troubleshoot technical issues during equipment operation, document Breakdown Analysis (BDA) and lessons learned for equipment-related problems.Provide technical support during internal audits, FDA/EMA/HSA inspections, and client audits.Support deviation investigations, CAPA development, change control, periodic reviews, and risk assessments (HAZOP, FMEA, CMMS updates).Ensure timely and accurate updates of system documentation (SOPs, Maximo job plans, equipment files).Continuously identify and eliminate potential audit risks to achieve audit readiness as a routine practice.Other tasks assigned by superior.
REQUIREMENTS: Must be flexible to work in a 24/7 shift rotation.New graduates with a bachelor's degree or higher, 2 years or above relevant maintenance experience in pharmaceutical manufacturing is preferred.Good knowledge of GMP requirements and international standards.Good analytical, troubleshooting capabilities.Proficiency in English (written and spoken).