Merck Gruppe - MSD Sharp & Dohme
Senior Maintenance Leader ( Dong Nai)
Merck Gruppe - MSD Sharp & Dohme, Rahway, New Jersey, us, 07065
Basic Functions & Responsibilities
Oversight of all maintenance operations at the site, ensuring reliable and compliant performance of equipment, utilities, and facilities. Leadership of maintenance team in executing preventive and corrective maintenance, minimizing downtime, and ensuring systems function complied within GMP, safety, and environmental standards. Support capital projects, continuous improvement initiatives, and readiness for audits and inspections. Primary Activities
Lead planning, execution, and monitoring of preventive, predictive, and corrective maintenance for process equipment, utilities (electric power supply, water supply, purified water, wastewater treatment, fire prevention and protection, HVAC, dust extraction, clean steam, compressed air, etc.), and facility systems at Dong Nai Site. Ensure all maintenance activities comply with GMP, EHS, and regulatory requirements. Supervise and develop maintenance team, including technicians and supervisors, ensuring adequate training, performance management, and resource planning. Manage maintenance documentation, work orders, spare parts, equipment history, and calibration records in CMMS (Computerized Maintenance Management System as SAP). Monitor equipment performance and analyze downtime trends to drive reliability improvements. Coordinate closely with Production, Quality, Warehouse, and EHS to ensure equipment availability and operational continuity. Provide technical input into project commissioning, equipment qualification, and engineering changes. Prepare and manage maintenance budget, including spare parts, contracts, and outsourced services. Develop and monitor KPIs to track maintenance efficiency, response time, equipment reliability, and compliance. Lead or support audit readiness and root cause investigations of deviations or failures. Education, Experience & Competencies
Professional Competencies Required Strong technical expertise in mechanical, electrical, and automation systems in GMP environments. In-depth understanding of maintenance systems, asset management, and regulatory compliance. Proficiency in CMMS platforms and basic knowledge of calibration, validation, and equipment lifecycle management. Familiarity with cleanroom environments, environmental monitoring systems (EMS/BAS), and pharmaceutical process equipment. Strong troubleshooting skills and understanding of root cause analysis techniques (e.g., 5 Whys, FMEA, Fishbone). Desired Experience / Education
Bachelor’s degree in Mechanical, Electrical, Mechatronics, or Industrial Engineering (or relevant technical discipline). Minimum 5 years progressive experience in maintenance within a GMP pharmaceutical, biotech, or regulated manufacturing environment. At least 3 years in a supervisory or management role. Experience working with Quality Assurance, Validation, and Engineering functions. Familiarity with local regulatory requirements (e.g., GxP-WHO, ISO) is an advantage. Functional Competencies Required
Strong leadership and team management abilities. Good planning, organizational, and communication skills. Problem‑solving mindset and decision‑making confidence under pressure. Continuous improvement orientation (e.g., Lean, TPM, Six Sigma is a plus). Fluency in English; proficiency in the local language is an advantage. Required Skills
Accountability, Adaptability, Capital Projects, Computerized Maintenance Management Systems (CMMS), Critical Thinking, Data Analysis, Driving Continuous Improvement, Electrical Systems, Engineering Design, Environmental Management Systems (EMS), Environmental Monitoring, Equipment Maintenance, Fire Prevention, Fire Safety, GMP Compliance, Maintenance Scheduling, Manufacturing Processes, Mechanical Troubleshooting, Mechatronics, Operation Maintenance, Organizational Performance Management, Quality Assurance (QA), Regulatory Compliance, Root Cause Analysis (RCA) + 4 more.
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Oversight of all maintenance operations at the site, ensuring reliable and compliant performance of equipment, utilities, and facilities. Leadership of maintenance team in executing preventive and corrective maintenance, minimizing downtime, and ensuring systems function complied within GMP, safety, and environmental standards. Support capital projects, continuous improvement initiatives, and readiness for audits and inspections. Primary Activities
Lead planning, execution, and monitoring of preventive, predictive, and corrective maintenance for process equipment, utilities (electric power supply, water supply, purified water, wastewater treatment, fire prevention and protection, HVAC, dust extraction, clean steam, compressed air, etc.), and facility systems at Dong Nai Site. Ensure all maintenance activities comply with GMP, EHS, and regulatory requirements. Supervise and develop maintenance team, including technicians and supervisors, ensuring adequate training, performance management, and resource planning. Manage maintenance documentation, work orders, spare parts, equipment history, and calibration records in CMMS (Computerized Maintenance Management System as SAP). Monitor equipment performance and analyze downtime trends to drive reliability improvements. Coordinate closely with Production, Quality, Warehouse, and EHS to ensure equipment availability and operational continuity. Provide technical input into project commissioning, equipment qualification, and engineering changes. Prepare and manage maintenance budget, including spare parts, contracts, and outsourced services. Develop and monitor KPIs to track maintenance efficiency, response time, equipment reliability, and compliance. Lead or support audit readiness and root cause investigations of deviations or failures. Education, Experience & Competencies
Professional Competencies Required Strong technical expertise in mechanical, electrical, and automation systems in GMP environments. In-depth understanding of maintenance systems, asset management, and regulatory compliance. Proficiency in CMMS platforms and basic knowledge of calibration, validation, and equipment lifecycle management. Familiarity with cleanroom environments, environmental monitoring systems (EMS/BAS), and pharmaceutical process equipment. Strong troubleshooting skills and understanding of root cause analysis techniques (e.g., 5 Whys, FMEA, Fishbone). Desired Experience / Education
Bachelor’s degree in Mechanical, Electrical, Mechatronics, or Industrial Engineering (or relevant technical discipline). Minimum 5 years progressive experience in maintenance within a GMP pharmaceutical, biotech, or regulated manufacturing environment. At least 3 years in a supervisory or management role. Experience working with Quality Assurance, Validation, and Engineering functions. Familiarity with local regulatory requirements (e.g., GxP-WHO, ISO) is an advantage. Functional Competencies Required
Strong leadership and team management abilities. Good planning, organizational, and communication skills. Problem‑solving mindset and decision‑making confidence under pressure. Continuous improvement orientation (e.g., Lean, TPM, Six Sigma is a plus). Fluency in English; proficiency in the local language is an advantage. Required Skills
Accountability, Adaptability, Capital Projects, Computerized Maintenance Management Systems (CMMS), Critical Thinking, Data Analysis, Driving Continuous Improvement, Electrical Systems, Engineering Design, Environmental Management Systems (EMS), Environmental Monitoring, Equipment Maintenance, Fire Prevention, Fire Safety, GMP Compliance, Maintenance Scheduling, Manufacturing Processes, Mechanical Troubleshooting, Mechatronics, Operation Maintenance, Organizational Performance Management, Quality Assurance (QA), Regulatory Compliance, Root Cause Analysis (RCA) + 4 more.
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