岗位职责:
1.Team Leadership & Management
-Lead, train, and supervise the packaging equipment team (including technicians and engineers) to assign daily tasks, conduct performance appraisals, and foster a culture of safety and compliance.
-Develop and implement team training programs on pharmaceutical equipment maintenance, GMP regulations, and safety protocols.
2.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.
3.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.
4.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.
5.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.
6.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.
7.Other task form direct manager
任职要求:
1. Bachelor degree or above,Engineering, Automation, Electrical, Mechanics technologies related
2. English in speaking, reading and writing
3. 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.
-Familiar with GMP related regulation requirements.
-Pharmaceutical process system, and its operation, maintenance.
-Proficiency in maintenance management software (CMMS) and Microsoft Office Suite (especially Project).
-Proficient in structure and maintenance of common pharmaceutical OSD packaging equipment (blister, bottle, sachet, stick packaging)