Job Description BASIC FUNCTIONS & RESPONSABILITIES: - The Senior Maintenance Leader is responsible for overseeing all maintenance operations at the site, ensuring the reliable and compliant performance of equipment, utilities, and facilities. - This role leads the maintenance team in executing preventive and corrective maintenance programs, minimizing downtime, and ensuring all systems function complied within GMP, safety, and environmental standards. - The Senior Maintenance Leader also supports capital projects, continuous improvement initiatives, and readiness for audits and inspections. PRIMARY ACTIVITIES: - Lead the planning, execution, and monitoring of preventive, predictive, and corrective maintenance for process equipment, utility (electric power supply, water supply, purified water, waste water 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 the 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 the 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 of 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, 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} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Not Applicable Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 01/15/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
