固体制剂设备高级工程师(J24788)

1. 01

   Equipment Maintenance & Reliability  Develop and execute preventive maintenance (PM) plans for all production equipment.  Oversee troubleshooting and corrective maintenance of equipment breakdowns, minimizing production downtime and ensuring root cause analysis (RCA) is conducted for recurring issues.  Ensure the reliability and stability of process equipment to meet production quality and yield targets.

2. 02

   Compliance & Documentation  Ensure all maintenance activities are performed in compliance with GMP, EHS, FDA guidelines, and company SOPs.  Manage and maintain accurate maintenance records, equipment history files, calibration certificates, and validation documentation.  Coordinate with the Quality Assurance (QA) department to support audits and inspections related to equipment maintenance.

3. 03

   Budget & Spare Parts Management  Develop and manage the annual maintenance budget, including costs for spare parts, contractor services, and tooling.  Oversee the inventory management of critical spare parts to ensure availability while minimizing excess inventory.  Evaluate and select reliable vendors for spare parts and maintenance services, negotiating contracts to optimize cost and quality.

4. 04

   Project Management  Lead end-to-end execution of equipment-related projects, including new equipment installation, production line upgrade, equipment relocation, and technology transformation initiatives in the pharmaceutical facility.  Define project scope, objectives, and deliverables; develop detailed project plans, including timelines, resource allocation, and risk mitigation strategies.  Coordinate cross-functional teams (engineering, production, QA, procurement) to ensure project alignment with operational and regulatory requirements; track project progress, resolve bottlenecks, and report status to senior management regularly.  Conduct project closure reviews, document lessons learned, and implement best practices to improve future project performance.

5. 05

   Continuous Improvement  Identify opportunities for equipment and process optimization to improve efficiency, reduce maintenance costs, and enhance product quality.  Lead or participate in continuous improvement projects (e.g., TPM - Total Productive Maintenance) to drive operational excellence.  Evaluate and implement new maintenance technologies or practices to enhance team performance.

6. 06

   Other task form direct manager

Bachelor degree or above Engineering, Automation, Electrical, Mechanics technologies related English in speaking, reading and writing N/A Minimum of 5-8 years of experience in equipment maintenance, with at least 3 years in a supervisory or managerial role in the pharmaceutical manufacturing industry.

1. 01

   Familiar with GMP related regulation requirements.

2. 02

   Pharmaceutical process system, and its operation, maintenance.

3. 03

   Proficiency in maintenance management software (CMMS) and Microsoft Office Suite (especially Project).

4. 04

   Proficient in structure and maintenance of common pharmaceutical OSD equipment