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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.
Job Responsibility:
Responsible for the full lifecycle management of all automated equipment and control systems (such as PLC, SCADA, MES, DCS, BMS, EMS, etc.)
Ensure automation systems meet data integrity regulatory requirements
establish SOPs for routine data integrity maintenance
Develop daily operation and maintenance management systems, safety operating procedures, and emergency response plans for automation systems
Responsible for compliance management of automation systems
coordinate with internal audits and external regulatory inspections (EMEA, PIC/S, NMPA, etc.)
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.)
Monitor trends in automation and intelligent technologies in the pharmaceutical industry
propose optimization and upgrade recommendations for automation systems
Collaborate with Production, Quality Control, and Warehousing departments to optimize automation processes
Maintain close communication with relevant departments such as Production, Quality, Procurement, and Warehousing
Report regularly to the Engineering Director on automation system operation status, team progress, project advancement, and existing issues
Responsible for communication and coordination with external suppliers, technical service providers, and regulatory authorities
Responsible for cost control related to automation
develop annual O&M budgets and project budgets
Implement safety production responsibility systems
organize safety training and emergency drills for the automation team
Proactively establish regular communication mechanisms with the Global Engineering automation team
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
Lead the automation team, guide and coordinate the work of team members
Organize training for team members
Allocate team resources reasonably
Establish effective communication channels
Coordinate work within the team and across departments and resolve conflicts and issues
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
Other work assigned by superior
Requirements:
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
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
Nice to have:
Master’s degree
Experience in foreign-invested pharmaceutical manufacturing enterprises
Experience in automation management in pharmaceutical facilities
Experience managing automation teams in pharmaceutical facilities
Experience implementing automation projects on pharmaceutical production lines
Experience with external regulatory inspections (NMPA, etc.) and internal audits
Relevant professional certifications (e.g., Automation Engineer Certificate, PMP)