Job purpose：
Responsible for the planning, implementation, operation, maintenance, optimization, and team management of plant automation systems, including production, quality control, warehousing, and related automated equipment and control systems. The core objectives are to ensure compliant, stable, and efficient operation of automation systems in alignment with international pharmaceutical industry requirements such as cGMP and ISPE standards, enhance production efficiency, reduce operating costs, ensure product quality, support the sustainable and robust development of manufacturing and commercial operations, and drive the automation and intelligent upgrading of the facility.
Main Responsibilities, Activities, Duties and Tasks:
- Part I: Automation System Management
- Responsible for the full lifecycle management of all automated equipment and control systems (such as PLC, SCADA, MES, DCS, BMS, EMS, etc.), including selection, procurement evaluation, installation and commissioning, routine operation and maintenance, troubleshooting, and periodic calibration. Ensure that equipment and systems comply with global cGMP pharmaceutical industry regulatory requirements and ISPE industry standards, with zero compliance risks.
- Ensure automation systems meet data integrity regulatory requirements; establish SOPs for routine data integrity maintenance, standardizing processes for account management, data storage security, system audit trails and traceability, program/software and data backup, and data recovery.
- Develop daily operation and maintenance management systems, safety operating procedures, and emergency response plans for automation systems; organize and implement O&M plans, conduct regular system inspections, promptly address equipment failures and system anomalies, ensure smooth operation of automated processes in production, quality control, and warehousing, and minimize downtime.
- Responsible for compliance management of automation systems; coordinate with internal audits and external regulatory inspections (EMEA, PIC/S, NMPA, etc.); compile and archive O&M records, calibration reports, change records, and other documentation related to automation to ensure full traceability of all operations.
- Part II: Project Management & Optimization Upgrade
- Responsible for the overall management of automation-related projects (such as automation setup for new production lines, upgrade and renovation of existing systems, introduction of intelligent equipment, etc.), from project initiation, scheme design, cost budgeting, and schedule control to completion acceptance. Follow through the entire process to ensure projects are completed on time, with quality, and within budget, while meeting compliance requirements. Monitor trends in automation and intelligent technologies in the pharmaceutical industry; propose optimization and upgrade recommendations for automation systems based on business production and operational needs; evaluate technical feasibility and return on investment (ROI); drive technology implementation to enhance plant automation and intelligence levels.
- Collaborate with Production, Quality Control, and Warehousing departments to optimize automation processes according to business requirements, improve production efficiency, product quality, and operational safety, and reduce labor costs and material losses.
- Part III: Cross-Functional Collaboration & Compliance Communication
- Maintain close communication with relevant departments such as Production, Quality, Procurement, and Warehousing; coordinate and resolve cross-functional collaboration issues related to automation to ensure smooth workflow integration across all stages.
- Report regularly to the Engineering Director on automation system operation status, team progress, project advancement, and existing issues; propose improvement recommendations and execute other tasks assigned by senior management.
- Responsible for communication and coordination with external suppliers, technical service providers, and regulatory authorities; handle technical consultations, after-sales services, compliance inspections, and other matters related to automated equipment and systems.
- Part IV: Cost & Safety Management
- Responsible for cost control related to automation; develop annual O&M budgets and project budgets; reasonably control expenses for equipment procurement, operation and maintenance, training, etc., to improve capital utilization efficiency.
- Implement safety production responsibility systems; organize safety training and emergency drills for the automation team; identify and eliminate safety hazards in automation systems; ensure equipment operational safety and personnel operational safety, preventing safety incidents.
- Part V: Collaboration with Global Engineering Team
- Proactively establish regular communication mechanisms with the Global Engineering automation team; regularly participate in global technical sharing sessions, standard reviews, and digital project retrospectives to stay abreast of cutting-edge trends in pharmaceutical automation at the earliest opportunity.
- Based on the full absorption of global best practices, distill and refining innovative local practices in automation system optimization, energy-saving control, or compliant data management.
- Part VI: Team Management
- Lead the automation team, guide and coordinate the work of team members, enhance the capabilities of the team, and ensure that business operations are standardized and efficient.
- Organize training for team members to ensure they promptly acquire the knowledge and skills required for their positions and conduct assessments.
- Allocate team resources reasonably to ensure that each member can maximize their potential in the right position.
- Establish effective communication channels to ensure the flow of information within the team and across departments.
- Coordinate work within the team and across departments and resolve conflicts and issues.
- Part VII: Others
- Aware of and comply with the corporate and local Quality/EHS Manual, Quality/EHS Management System, Quality/EHS Management Policy, Quality/EHS Goals, and applicable laws and regulations as they apply to this job type/position.
- Other work assigned by superior.
Education：
• Bachelor's degree or above in Automation, Electrical Engineering and Automation, Measurement and Control Technology and Instruments, Process Equipment and Control Engineering, or related majors; master’s degree preferred.
• Prior experience in foreign-invested pharmaceutical manufacturing enterprises preferred; familiarity with GMP and other compliance requirements in the pharmaceutical industry; experience in automation management in pharmaceutical facilities highly preferred.
Professional Experience, Knowledge & Technical Skills
• 5-8+ years of experience in automation-related fields, including 3+ years in team management; experience in managing automation teams in pharmaceutical facilities preferred.
• Hands-on experience in O&M, optimization, and project management of automation systems (PLC, SCADA, MES, DCS, etc.); experience in implementing automation projects on pharmaceutical production lines preferred.
• Experience participating in external regulatory inspections (NMPA, etc.) and internal audits; familiarity with automation-related compliance requirements and documentation management standards in the pharmaceutical industry preferred.
• Proficient in automation control principles; skilled in PLC programming, SCADA/DCS/MES system operation and maintenance; capable of independently troubleshooting automated equipment and system failures.
• Demonstrated project management capabilities for automation projects; able to independently manage the full project lifecycle from initiation to implementation; familiar with project cost budgeting, schedule management, and quality control methodologies.
• Understanding of pharmaceutical manufacturing processes (e.g., formulation, API production, etc.); familiar with compliance requirements for automation equipment and systems in the pharmaceutical industry; able to ensure automation activities comply with GMP and other regulatory standards.
• Willing to accept necessary overtime and on-site plant inspections; no occupational contraindications.
• Relevant professional certifications (e.g., Automation Engineer Certificate, PMP, etc.) preferred. • Strictly comply with National laws and regulations, EHS and quality management system, abide by the company Code of Conduct, rules and regulations. Ensure that all work behavior conform to company's compliance requirements.
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